Prevacid SoluTab
- Product NDC
- 64764-543
- 11-digit product format
- 647640543
- Labeler code
- 64764
- Product ID
- 64764-543_45f1d5ff-d884-4e40-a16c-313a4e21e32c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lansoprazole
- Dosage form
- TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- NDA021428
- Marketing category
- NDA
- Marketing start
- 2002-08-30
- Substance
- LANSOPRAZOLE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021428-001 | PREVACID | LANSOPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 |
| N021428-002 | PREVACID | LANSOPRAZOLE | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021428-001 | AB |
| N021428-002 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021428-001 | PREVACID | 15MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD | 2002-08-30 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021428-002 | PREVACID | 30MG | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | AB | RLD, RS | 2002-08-30 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021428-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021428-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021428-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021428-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021428-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021428-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021428-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021428-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021428-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021428-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021428-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021428-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021428-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021428-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021428-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021428-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021428-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021428-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021428-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021428-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021428-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021428-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021428-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021428-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021428-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021428-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021428-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021428-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021428-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021428-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021428-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021428-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021428-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021428-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021428-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021428-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021428-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021428-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021428-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021428-002 | AB | 1 | bb7c543d1eb4… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021428-001 | 6328994 | 2019-05-17 | 2002-10-28 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021428-001 | 7431942 | 2019-05-17 | Drug product | 2009-01-22 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021428-001 | 7875292 | 2019-05-17 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021428-001 | 9901546 | 2019-05-17 | Drug product | 2018-04-26 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021428-001 | 6328994*PED | 2019-11-17 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021428-001 | 7431942*PED | 2019-11-17 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021428-001 | 7875292*PED | 2019-11-17 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021428-001 | 9901546*PED | 2019-11-17 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021428-002 | 6328994 | 2019-05-17 | 2002-10-28 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021428-002 | 7431942 | 2019-05-17 | Drug product | 2009-01-22 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021428-002 | 7875292 | 2019-05-17 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021428-002 | 9901546 | 2019-05-17 | Drug product | 2018-04-26 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021428-002 | 6328994*PED | 2019-11-17 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021428-002 | 7431942*PED | 2019-11-17 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021428-002 | 7875292*PED | 2019-11-17 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021428-002 | 9901546*PED | 2019-11-17 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021428-001 | 6328994 | 2019-05-17 | 2002-10-28 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021428-001 | 7431942 | 2019-05-17 | Drug product | 2009-01-22 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021428-001 | 7875292 | 2019-05-17 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021428-001 | 9901546 | 2019-05-17 | Drug product | 2018-04-26 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021428-001 | 6328994*PED | 2019-11-17 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021428-001 | 7431942*PED | 2019-11-17 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021428-001 | 7875292*PED | 2019-11-17 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021428-001 | 9901546*PED | 2019-11-17 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021428-002 | 6328994 | 2019-05-17 | 2002-10-28 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021428-002 | 7431942 | 2019-05-17 | Drug product | 2009-01-22 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021428-002 | 7875292 | 2019-05-17 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021428-002 | 9901546 | 2019-05-17 | Drug product | 2018-04-26 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021428-002 | 6328994*PED | 2019-11-17 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021428-002 | 7431942*PED | 2019-11-17 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021428-002 | 7875292*PED | 2019-11-17 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021428-002 | 9901546*PED | 2019-11-17 | Pediatric extension | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021428-001 | 6328994 | 2019-05-17 | 2002-10-28 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021428-001 | 7431942 | 2019-05-17 | Drug product | 2009-01-22 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021428-001 | 7875292 | 2019-05-17 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021428-001 | 9901546 | 2019-05-17 | Drug product | 2018-04-26 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021428-001 | 6328994*PED | 2019-11-17 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021428-001 | 7431942*PED | 2019-11-17 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021428-001 | 7875292*PED | 2019-11-17 | Pediatric extension | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021428-001 | 9901546*PED | 2019-11-17 | Pediatric extension | b00525d2431f… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Prevacid SoluTab
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LANSOPRAZOLE | 15 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0K5C5T2QPG | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 71ba78cb-7e46-43eb-9425-fa130f537f84 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d6b97638-59f4-48e2-8959-569628732c46 | Product name | 9 | 20210622 |
| 8690a824-4bf8-4d1e-b118-2d6dda86bc04 | Product name | 2 | 20161206 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64764-543-05 | Prevacid SoluTab | 5 in 1 TRAY | TABLET, ORALLY DISINTEGRATING, D | 5 | 45 | |
| 64764-543-05 | Prevacid SoluTab | 3 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING, D | 3 | 45 | |
| 64764-543-11 | Prevacid SoluTab | 10 in 1 CARTON | TABLET, ORALLY DISINTEGRATING, D | 10 | 45 | |
| 64764-543-30 | Prevacid SoluTab | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING, D | 10 | 45 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64764-543-11 | EA - Each | 64764-543 | 8732a38e-ebc0-45c6-8c38-ac29fb873fd7 | 1 | 2012-07-24 |
| 64764-543-30 | EA - Each | 64764-543 | bbc342cd-821a-416f-8551-6e114e37b2c6 | 1 | 2019-01-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64764-543 | PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID SOLUTAB (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 44 | Current NDC, Legacy NDC, 4 package rows | 20230913_71ba78cb-7e46-43eb-9425-fa130f537f84.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Prevacid | LANSOPRAZOLE | Takeda Pharmaceuticals America, Inc. | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 2025-07-08 | Warnings, Adverse reactions | 021428 NDA021428 64764-543 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 351261 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 351260 | lansoprazole 30 MG Delayed Release Disintegrating Oral Tablet | PSN | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 311277 | lansoprazole 30 MG Delayed Release Oral Capsule | PSN | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 206206 | Prevacid 30 MG Delayed Release Oral Capsule | PSN | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 206205 | Prevacid SoluTab 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 866152 | Prevacid SoluTab 30 MG Delayed Release Disintegrating Oral Tablet | PSN | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 206205 | lansoprazole 15 MG Disintegrating Oral Tablet [Prevacid] | SBD | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 206206 | lansoprazole 30 MG Delayed Release Oral Capsule [Prevacid] | SBD | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 866152 | lansoprazole 30 MG Disintegrating Oral Tablet [Prevacid] | SBD | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 351261 | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 311277 | lansoprazole 30 MG Delayed Release Oral Capsule | SCD | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 351260 | lansoprazole 30 MG Disintegrating Oral Tablet | SCD | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 351261 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 351260 | lansoprazole 30 MG Delayed Release Disintegrating Oral Tablet | SY | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 206205 | Prevacid 15 MG Delayed Release Disintegrating Oral Tablet | SY | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 866152 | Prevacid 30 MG Delayed Release Disintegrating Oral Tablet | SY | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 206206 | Prevacid 30 MG Delayed Release Oral Capsule | SY | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 206205 | Prevacid SoluTab 15 MG Delayed Release Disintegrating Oral Tablet | SY | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 866152 | Prevacid SoluTab 30 MG Delayed Release Disintegrating Oral Tablet | SY | 71ba78cb-7e46-43eb-9425-fa130f537f84 | 45 |
| 351261 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 596843 | lansoprazole 15 MG Delayed Release Oral Capsule | PSN | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 351260 | lansoprazole 30 MG Delayed Release Disintegrating Oral Tablet | PSN | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 311277 | lansoprazole 30 MG Delayed Release Oral Capsule | PSN | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 596918 | Prevacid 15 MG Delayed Release Oral Capsule | PSN | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 206206 | Prevacid 30 MG Delayed Release Oral Capsule | PSN | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 206205 | Prevacid SoluTab 15 MG Delayed Release Disintegrating Oral Tablet | PSN | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 866152 | Prevacid SoluTab 30 MG Delayed Release Disintegrating Oral Tablet | PSN | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 596918 | lansoprazole 15 MG Delayed Release Oral Capsule [Prevacid] | SBD | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 206205 | lansoprazole 15 MG Disintegrating Oral Tablet [Prevacid] | SBD | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 206206 | lansoprazole 30 MG Delayed Release Oral Capsule [Prevacid] | SBD | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 866152 | lansoprazole 30 MG Disintegrating Oral Tablet [Prevacid] | SBD | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 596843 | lansoprazole 15 MG Delayed Release Oral Capsule | SCD | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 351261 | lansoprazole 15 MG Disintegrating Oral Tablet | SCD | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 311277 | lansoprazole 30 MG Delayed Release Oral Capsule | SCD | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 351260 | lansoprazole 30 MG Disintegrating Oral Tablet | SCD | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 351261 | lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet | SY | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 351260 | lansoprazole 30 MG Delayed Release Disintegrating Oral Tablet | SY | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 206205 | Prevacid 15 MG Delayed Release Disintegrating Oral Tablet | SY | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 596918 | Prevacid 15 MG Delayed Release Oral Capsule | SY | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 866152 | Prevacid 30 MG Delayed Release Disintegrating Oral Tablet | SY | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 206206 | Prevacid 30 MG Delayed Release Oral Capsule | SY | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 206205 | Prevacid SoluTab 15 MG Delayed Release Disintegrating Oral Tablet | SY | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
| 866152 | Prevacid SoluTab 30 MG Delayed Release Disintegrating Oral Tablet | SY | 7140f8d9-e478-4f69-a4eb-3fd4c9414576 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 64764-543-05 | 64764054305 | 5 BLISTER PACK in 1 TRAY (64764-543-05) / 3 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | 5 blister pack | 2002-08-30 | 0000-00-00 | No | No | Current |
| 64764-543-11 | 64764054311 | 10 BLISTER PACK in 1 CARTON (64764-543-11) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (64764-543-30) | 10 blister pack | 2002-08-30 | 0000-00-00 | No | No | Current |
| 64764-543-30 | 64764054330 | 10 in 1 BLISTER PACK | Historical |