NDC properties for NDC 9 0054-0348
NDC item 00054034807
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-07 |
| NDC Item | 00054034807 |
| packaging | 20 TABLET, FILM COATED in 1 BOTTLE (0054-0348-07) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
NDC item 00054034821
| NDC 9 | 0054-0348 |
|---|---|
| NDC 10 | 0054-0348-21 |
| NDC Item | 00054034821 |
| packaging | 60 TABLET, FILM COATED in 1 BOTTLE (0054-0348-21) |
| ANDA | ANDA201172 |
| COLORTEXT | WHITE(Off White) |
| Color | C48325 __ |
| FDA SPL set id | 611868 |
| Imprint code | 54455 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-10-31 |
| Marketing effective time low | 2012-04-30 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Modified |
| Shape | C48345 |
| Size | 16 mm |
NDC item 16571021506
| NDC 9 | 16571-215 |
|---|---|
| NDC 10 | 16571-215-06 |
| NDC Item | 16571021506 |
| packaging | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16571-215-06) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 114445 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2013-10-10 |
| Marketing effective time low | 2013-10-09 |
| Marketing status | COMPLETED |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
NDC item 42799020801
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-01 |
| NDC Item | 42799020801 |
| packaging | 20 TABLET in 1 BOTTLE (42799-208-01) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
NDC item 42799020802
| NDC 9 | 42799-208 |
|---|---|
| NDC 10 | 42799-208-02 |
| NDC Item | 42799020802 |
| packaging | 60 TABLET in 1 BOTTLE (42799-208-02) |
| ANDA | ANDA203808 |
| COLORTEXT | YELLOW |
| Color | C48330 __ |
| FDA SPL set id | 624893 |
| Imprint code | 208 |
| Labeler | Edenbridge Pharmaceuticals LLC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-12-20 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
NDC item 43386055102
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-02 |
| NDC Item | 43386055102 |
| packaging | 20 TABLET in 1 BOTTLE (43386-551-02) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
NDC item 43386055106
| NDC 9 | 43386-551 |
|---|---|
| NDC 10 | 43386-551-06 |
| NDC Item | 43386055106 |
| packaging | 60 TABLET in 1 BOTTLE (43386-551-06) |
| ANDA | ANDA202044 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 716141 |
| Imprint code | NL;551 |
| Labeler | Lupin Pharmaceuticals,Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
NDC item 44523045020
| NDC 9 | 44523-450 |
|---|---|
| NDC 10 | 44523-450-20 |
| NDC Item | 44523045020 |
| packaging | 20 TABLET in 1 BOTTLE (44523-450-20) |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 71195 |
| Imprint code | TM;500 |
| Labeler | Biocomp Pharma, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Marketing effective time high | 2019-02-05 |
| Marketing effective time low | 2012-06-07 |
| Marketing status | COMPLETED |
| NDA_AUTHORIZED_GENERIC | NDA021618 |
| Score | 2 |
| Shape | C48345 |
| Size | 14 mm |
NDC item 62135083520
| NDC 9 | 62135-835 |
|---|---|
| NDC 10 | 62135-835-20 |
| NDC Item | 62135083520 |
| packaging | 20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20) |
| ANDA | ANDA202044 |
| COLORTEXT | white(white to off-white) |
| Color | C48325 __ |
| FDA SPL set id | 798224 |
| Imprint code | C;E;205 |
| Labeler | Chartwell RX, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-04-30 |
| Marketing status | active |
| Score | 2 |
| Shape | C48345 |
| Size | 16 mm |
NDC item 64980042712
| NDC 9 | 64980-427 |
|---|---|
| NDC 10 | 64980-427-12 |
| NDC Item | 64980042712 |
| packaging | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12) |
| ANDA | ANDA202489 |
| COLORTEXT | PINK |
| Color | C48328 __ |
| FDA SPL set id | 717670 |
| Imprint code | TP;500 |
| Labeler | Rising Pharma Holdings, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
NDC item 67296183608
| NDC 9 | 67296-1836 |
|---|---|
| NDC 10 | 67296-1836-8 |
| NDC Item | 67296183608 |
| packaging | 8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 798328 |
| Imprint code | TP;500 |
| Labeler | Redpharm Drug, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2013-10-09 |
| Marketing status | ACTIVE |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
NDC item 70518417200
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-0 |
| NDC Item | 70518417200 |
| packaging | 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-0) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |
NDC item 70518417201
| NDC 9 | 70518-4172 |
|---|---|
| NDC 10 | 70518-4172-1 |
| NDC Item | 70518417201 |
| packaging | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4172-1) |
| ANDA | ANDA202489 |
| COLORTEXT | pink |
| Color | C48328 __ |
| FDA SPL set id | 807843 |
| Imprint code | TP;500 |
| Labeler | REMEDYREPACK INC. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-08-30 |
| Marketing status | active |
| Score | 2 |
| Shapetext | Capsule Shaped |
| Shape | C48336 |
| Size | 16 mm |