NDC properties for NDC 9 0378-3120
NDC item 00378312093
| NDC 9 | 0378-3120 |
|---|---|
| NDC 10 | 0378-3120-93 |
| NDC Item | 00378312093 |
| packaging | 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93) |
| ANDA | ANDA070920 |
| COLORTEXT | YELLOW(yellow opaque),ORANGE(peach opaque) |
| Color | C48330;C48331 __ |
| DCSA | CIV |
| FDA SPL set id | 411913 |
| Imprint code | MYLAN;3120 |
| Labeler | Mylan Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2019-10-31 |
| Marketing effective time low | 2009-06-15 |
| Marketing status | COMPLETED |
| Score | 1 |
| Shape | C48336 |
| Size | 16 mm |
NDC item 00406995903
| NDC 9 | 0406-9959 |
|---|---|
| NDC 10 | 0406-9959-03 |
| NDC Item | 00406995903 |
| packaging | 30 CAPSULE in 1 BOTTLE (0406-9959-03) |
| COLORTEXT | blue |
| Color | C48333 __ |
| DCSA | CIV |
| FDA SPL set id | 786605 |
| Imprint code | FOR;SLEEP;M;22;5;mg |
| Labeler | SpecGx LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2010-02-23 |
| Marketing status | ACTIVE |
| NDA | NDA018163 |
| Score | 1 |
| Shape | C48336 |
| Size | 16 mm |
NDC item 35356082130
| NDC 9 | 35356-821 |
|---|---|
| NDC 10 | 35356-821-30 |
| NDC Item | 35356082130 |
| packaging | 30 CAPSULE in 1 BOTTLE (35356-821-30) |
| ANDA | ANDA071457 |
| COLORTEXT | blue(light blue opaque cap),white(white opaque body) |
| Color | C48333;C48325 __ |
| DCSA | CIV |
| FDA SPL set id | 763028 |
| Imprint code | 22;5mg;Novel122 |
| Labeler | Lake Erie Medical DBA: Quality Care Products LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-06-28 |
| Marketing status | COMPLETED |
| Score | 1 |
| Shape | C48336 |
| Size | 19 mm |
NDC item 43547061303
| NDC 9 | 43547-613 |
|---|---|
| NDC 10 | 43547-613-03 |
| NDC Item | 43547061303 |
| packaging | 30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03) |
| ANDA | ANDA201781 |
| COLORTEXT | BLUE(Opaque Blue) |
| Color | C48333 __ |
| DCSA | CIV |
| FDA SPL set id | 812831 |
| Imprint code | 22;5mg;S613 |
| Labeler | Solco Healthcare U.S., LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2023-01-05 |
| Marketing status | ACTIVE |
| Score | 1 |
| Shape | C48336 |
| Size | 16 mm |
NDC item 46708038130
| NDC 9 | 46708-381 |
|---|---|
| NDC 10 | 46708-381-30 |
| NDC Item | 46708038130 |
| packaging | 30 CAPSULE in 1 BOTTLE (46708-381-30) |
| ANDA | ANDA211542 |
| COLORTEXT | BLUE(opaque blue cap opaque blue body) |
| Color | C48333 __ |
| DCSA | CIV |
| FDA SPL set id | 690537 |
| Imprint code | A224 |
| Labeler | Alembic Pharmaceuticals Limited |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-11-27 |
| Marketing status | ACTIVE |
| Score | 1 |
| Shape | C48336 |
| Size | 16 mm |
NDC item 50436463001
| NDC 9 | 50436-4630 |
|---|---|
| NDC 10 | 50436-4630-1 |
| NDC Item | 50436463001 |
| packaging | 30 CAPSULE in 1 BOTTLE (50436-4630-1) |
| ANDA | ANDA071457 |
| COLORTEXT | blue(light blue opaque cap),white(white opaque body) |
| Color | C48333;C48325 __ |
| DCSA | CIV |
| FDA SPL set id | 260509 |
| Imprint code | 22;5mg;Novel122 |
| Labeler | Unit Dose Services |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-06-28 |
| Marketing status | ACTIVE |
| Score | 1 |
| Shape | C48336 |
| Size | 19 mm |
NDC item 53489065007
| NDC 9 | 53489-650 |
|---|---|
| NDC 10 | 53489-650-07 |
| NDC Item | 53489065007 |
| packaging | 30 CAPSULE in 1 BOTTLE, PLASTIC (53489-650-07) |
| ANDA | ANDA071175 |
| COLORTEXT | white(opaque),green(light green opaque) |
| Color | C48325;C48329 __ |
| DCSA | CIV |
| FDA SPL set id | 399603 |
| Imprint code | Mutual;868 |
| Labeler | Sun Pharmaceutical Industries Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-10-26 |
| Marketing status | ACTIVE |
| Score | 1 |
| Shape | C48336 |
| Size | 14 mm |
NDC item 60760095930
| NDC 9 | 60760-959 |
|---|---|
| NDC 10 | 60760-959-30 |
| NDC Item | 60760095930 |
| packaging | 30 CAPSULE in 1 BOTTLE, PLASTIC (60760-959-30) |
| COLORTEXT | blue |
| Color | C48333 __ |
| DCSA | CIV |
| FDA SPL set id | 428380 |
| Imprint code | FOR;SLEEP;M;22;5;mg |
| Labeler | St. Mary's Medical Park Pharmacy |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2019-10-24 |
| Marketing status | COMPLETED |
| NDA | NDA018163 |
| Score | 1 |
| Shape | C48336 |
| Size | 16 mm |
NDC item 62332038130
| NDC 9 | 62332-381 |
|---|---|
| NDC 10 | 62332-381-30 |
| NDC Item | 62332038130 |
| packaging | 30 CAPSULE in 1 BOTTLE (62332-381-30) |
| ANDA | ANDA211542 |
| COLORTEXT | BLUE(opaque blue cap opaque blue body) |
| Color | C48333 __ |
| DCSA | CIV |
| FDA SPL set id | 707869 |
| Imprint code | A224 |
| Labeler | Alembic Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-11-27 |
| Marketing status | ACTIVE |
| Score | 1 |
| Shape | C48336 |
| Size | 16 mm |
NDC item 63629860401
| NDC 9 | 63629-8604 |
|---|---|
| NDC 10 | 63629-8604-1 |
| NDC Item | 63629860401 |
| packaging | 30 CAPSULE in 1 BOTTLE (63629-8604-1) |
| ANDA | ANDA071457 |
| COLORTEXT | BLUE(blue opaque cap),WHITE(white opaque body) |
| Color | C48333;C48325 __ |
| DCSA | CIV |
| FDA SPL set id | 763276 |
| Imprint code | 22;5mg;Novel122 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-06-28 |
| Marketing status | ACTIVE |
| Score | 1 |
| Shape | C48336 |
| Size | 19 mm |
NDC item 65162058403
| NDC 9 | 65162-584 |
|---|---|
| NDC 10 | 65162-584-03 |
| NDC Item | 65162058403 |
| packaging | 30 CAPSULE in 1 BOTTLE (65162-584-03) |
| ANDA | ANDA203482 |
| COLORTEXT | white(OPAQUE BODY),pink(DARK PINK OPAQUE) |
| Color | C48325;C48328 __ |
| DCSA | CIV |
| FDA SPL set id | 824881 |
| Imprint code | AMNEAL;584 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2016-05-23 |
| Marketing status | ACTIVE |
| Score | 1 |
| Shape | C48336 |
| Size | 18 mm |
NDC item 65162058410
| NDC 9 | 65162-584 |
|---|---|
| NDC 10 | 65162-584-10 |
| NDC Item | 65162058410 |
| packaging | 100 CAPSULE in 1 BOTTLE (65162-584-10) |
| ANDA | ANDA203482 |
| COLORTEXT | white(OPAQUE BODY),pink(DARK PINK OPAQUE) |
| Color | C48325;C48328 __ |
| DCSA | CIV |
| FDA SPL set id | 824881 |
| Imprint code | AMNEAL;584 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2016-05-23 |
| Marketing status | ACTIVE |
| Score | 1 |
| Shape | C48336 |
| Size | 18 mm |
NDC item 65162058411
| NDC 9 | 65162-584 |
|---|---|
| NDC 10 | 65162-584-11 |
| NDC Item | 65162058411 |
| packaging | 1000 CAPSULE in 1 BOTTLE (65162-584-11) |
| ANDA | ANDA203482 |
| COLORTEXT | white(OPAQUE BODY),pink(DARK PINK OPAQUE) |
| Color | C48325;C48328 __ |
| DCSA | CIV |
| FDA SPL set id | 824881 |
| Imprint code | AMNEAL;584 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2016-05-23 |
| Marketing status | ACTIVE |
| Score | 1 |
| Shape | C48336 |
| Size | 18 mm |
NDC item 65162058450
| NDC 9 | 65162-584 |
|---|---|
| NDC 10 | 65162-584-50 |
| NDC Item | 65162058450 |
| packaging | 500 CAPSULE in 1 BOTTLE (65162-584-50) |
| ANDA | ANDA203482 |
| COLORTEXT | white(OPAQUE BODY),pink(DARK PINK OPAQUE) |
| Color | C48325;C48328 __ |
| DCSA | CIV |
| FDA SPL set id | 824881 |
| Imprint code | AMNEAL;584 |
| Labeler | Amneal Pharmaceuticals LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2016-05-23 |
| Marketing status | ACTIVE |
| Score | 1 |
| Shape | C48336 |
| Size | 18 mm |
NDC item 67877014901
| NDC 9 | 67877-149 |
|---|---|
| NDC 10 | 67877-149-01 |
| NDC Item | 67877014901 |
| packaging | 100 CAPSULE in 1 BOTTLE (67877-149-01) |
| ANDA | ANDA071457 |
| COLORTEXT | BLUE(blue opaque cap),WHITE(white opaque body) |
| Color | C48333;C48325 __ |
| DCSA | CIV |
| FDA SPL set id | 757749 |
| Imprint code | 22;5mg;Novel122 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-06-28 |
| Marketing status | ACTIVE |
| Score | 1 |
| Shape | C48336 |
| Size | 19 mm |
NDC item 67877014905
| NDC 9 | 67877-149 |
|---|---|
| NDC 10 | 67877-149-05 |
| NDC Item | 67877014905 |
| packaging | 500 CAPSULE in 1 BOTTLE (67877-149-05) |
| ANDA | ANDA071457 |
| COLORTEXT | BLUE(blue opaque cap),WHITE(white opaque body) |
| Color | C48333;C48325 __ |
| DCSA | CIV |
| FDA SPL set id | 757749 |
| Imprint code | 22;5mg;Novel122 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-06-28 |
| Marketing status | ACTIVE |
| Score | 1 |
| Shape | C48336 |
| Size | 19 mm |
NDC item 67877014930
| NDC 9 | 67877-149 |
|---|---|
| NDC 10 | 67877-149-30 |
| NDC Item | 67877014930 |
| packaging | 30 CAPSULE in 1 BOTTLE (67877-149-30) |
| ANDA | ANDA071457 |
| COLORTEXT | BLUE(blue opaque cap),WHITE(white opaque body) |
| Color | C48333;C48325 __ |
| DCSA | CIV |
| FDA SPL set id | 757749 |
| Imprint code | 22;5mg;Novel122 |
| Labeler | Ascend Laboratories, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-06-28 |
| Marketing status | ACTIVE |
| Score | 1 |
| Shape | C48336 |
| Size | 19 mm |
NDC item 71335204301
| NDC 9 | 71335-2043 |
|---|---|
| NDC 10 | 71335-2043-1 |
| NDC Item | 71335204301 |
| packaging | 30 CAPSULE in 1 BOTTLE (71335-2043-1) |
| ANDA | ANDA211542 |
| COLORTEXT | BLUE(opaque blue cap opaque blue body) |
| Color | C48333 __ |
| DCSA | CIV |
| FDA SPL set id | 748413 |
| Imprint code | A224 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2018-11-27 |
| Marketing status | ACTIVE |
| Score | 1 |
| Shape | C48336 |
| Size | 16 mm |
NDC item 72162182703
| NDC 9 | 72162-1827 |
|---|---|
| NDC 10 | 72162-1827-3 |
| NDC Item | 72162182703 |
| packaging | 30 CAPSULE in 1 BOTTLE (72162-1827-3) |
| ANDA | ANDA071457 |
| COLORTEXT | BLUE(blue opaque cap),WHITE(white opaque body) |
| Color | C48333;C48325 __ |
| DCSA | CIV |
| FDA SPL set id | 774627 |
| Imprint code | 22;5mg;Novel122 |
| Labeler | Bryant Ranch Prepack |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-06-28 |
| Marketing status | ACTIVE |
| Score | 1 |
| Shape | C48336 |
| Size | 19 mm |