Protonix
- Product NDC
- 0008-0844
- 11-digit product format
- 000080844
- Labeler code
- 0008
- Product ID
- 0008-0844_b1adaee5-9353-48ce-bde4-f169a3787e30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PANTOPRAZOLE SODIUM
- Dosage form
- GRANULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Application
- NDA022020
- Marketing category
- NDA
- Marketing start
- 2008-02-29
- Substance
- PANTOPRAZOLE SODIUM
- Active strength
- 40 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022020-001 | PROTONIX | PANTOPRAZOLE SODIUM | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022020-001 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022020-001 | 7544370 | 2026-06-07 | Drug product | ||
| N022020-001 | 7544370*PED | 2026-12-07 | Pediatric extension |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2007-11-14 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2007-11-14 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2007-11-14 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | RLD, RS | 2007-11-14 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022020-001 | PROTONIX | EQ 40MG BASE | FOR SUSPENSION, DELAYED RELEASE / ORAL | AB | RLD, RS | 2007-11-14 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022020-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022020-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022020-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022020-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022020-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022020-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022020-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022020-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022020-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022020-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022020-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022020-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022020-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022020-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022020-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022020-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022020-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N022020-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022020-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022020-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022020-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022020-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022020-001 | AB | 1 | c0c555d07b60… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022020-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022020-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022020-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022020-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022020-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022020-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022020-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022020-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022020-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022020-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022020-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022020-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022020-001 | AB | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N022020-001 | AB | 1 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022020-001 | 7544370 | 2026-06-07 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022020-001 | 7544370*PED | 2026-12-07 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022020-001 | 7550153 | 2024-09-30 | U-859 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022020-001 | 7553498 | 2024-09-30 | U-859 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022020-001 | 7838027 | 2024-09-30 | U-859 | Drug product | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022020-001 | 7550153*PED | 2025-03-30 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022020-001 | 7553498*PED | 2025-03-30 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022020-001 | 7838027*PED | 2025-03-30 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022020-001 | 7544370 | 2026-06-07 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022020-001 | 7544370*PED | 2026-12-07 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022020-001 | 7550153*PED | 2025-03-30 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022020-001 | 7553498*PED | 2025-03-30 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022020-001 | 7838027*PED | 2025-03-30 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022020-001 | 7544370 | 2026-06-07 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022020-001 | 7544370*PED | 2026-12-07 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022020-001 | 7550153*PED | 2025-03-30 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022020-001 | 7553498*PED | 2025-03-30 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022020-001 | 7838027*PED | 2025-03-30 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022020-001 | 7544370 | 2026-06-07 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022020-001 | 7544370*PED | 2026-12-07 | Pediatric extension | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022020-001 | 7550153*PED | 2025-03-30 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022020-001 | 7553498*PED | 2025-03-30 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022020-001 | 7838027*PED | 2025-03-30 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022020-001 | 7544370 | 2026-06-07 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022020-001 | 7544370*PED | 2026-12-07 | Pediatric extension | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022020-001 | 7550153 | 2024-09-30 | U-859 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022020-001 | 7553498 | 2024-09-30 | U-859 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022020-001 | 7838027 | 2024-09-30 | U-859 | Drug product | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022020-001 | 7550153*PED | 2025-03-30 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022020-001 | 7553498*PED | 2025-03-30 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022020-001 | 7838027*PED | 2025-03-30 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022020-001 | 7544370 | 2026-06-07 | Drug product | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022020-001 | 7544370*PED | 2026-12-07 | Pediatric extension | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022020-001 | 7550153 | 2024-09-30 | U-859 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022020-001 | 7553498 | 2024-09-30 | U-859 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022020-001 | 7838027 | 2024-09-30 | U-859 | Drug product | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022020-001 | 7550153*PED | 2025-03-30 | Pediatric extension | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022020-001 | 7553498*PED | 2025-03-30 | Pediatric extension | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022020-001 | 7838027*PED | 2025-03-30 | Pediatric extension | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022020-001 | 7544370 | 2026-06-07 | Drug product | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Protonix
- Brand name suffix
- Delayed-Release
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PANTOPRAZOLE SODIUM | 40 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6871619Q5X | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 08098cb2-c048-4640-f387-6beec4a38936 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ae9ebba7-ac9e-4a6e-90ef-4bd9760ec041 | Product name | 8 | 20260304 |
| 41d62193-73fc-49cf-9907-add9588e2da1 | Product name | 9 | 20260112 |
| f12d0d0d-c068-46c6-872c-96c9d38533bb | Product name | 1 | 20250116 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| edf5fdf1-aed1-42ea-b2a8-97b779f9aca4 | Product name | 1 | 20230718 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0008-0844-02 | 2024-01-30 | C162847 | 48780-1 | 1030e364-f951-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use PROTONIX safely and effectively. See full prescribing information for PROTONIX. PROTONIX (pantoprazole sodium) delayed-release tablets, for oral use PROTONIX (pantoprazole sodium) for delayed-release oral suspension Initial U.S. approval: 2000 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0008-0844-01 | ProtonixDelayed-Release | 1 in 1 PACKET | GRANULE, DELAYED RELEASE | 1 | 48 | |
| 0008-0844-02 | ProtonixDelayed-Release | 30 in 1 CARTON | GRANULE, DELAYED RELEASE | 30 | 48 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0008-0844-01 | EA - Each | 0008-0844 | a4a64248-a74b-44f3-85c5-bfd22d4cd462 | 1 | 2012-07-24 |
| 0008-0844-02 | EA - Each | 0008-0844 | 923dad3a-0648-4fe5-b4ea-526fe7657d8d | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0008-0844 | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.] | 47 | Current NDC, Legacy NDC, 2 package rows | 20240719_08098cb2-c048-4640-f387-6beec4a38936.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 |
|---|---|---|---|---|---|---|
| Protonix Delayed-Release | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 08098cb2-c048-4640-f387-6beec4a38936 | 2026-05-18 | Warnings, Adverse reactions | 022020 NDA022020 0008-0844 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 251872 | pantoprazole sodium 20 MG Delayed Release Oral Tablet | PSN | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763306 | pantoprazole sodium 40 MG Delayed Release Oral Granules | PSN | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 314200 | pantoprazole sodium 40 MG Delayed Release Oral Tablet | PSN | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 352125 | Protonix 20 MG Delayed Release Oral Tablet | PSN | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763308 | Protonix 40 MG Delayed Release Oral Granules | PSN | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 284400 | Protonix 40 MG Delayed Release Oral Tablet | PSN | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 352125 | pantoprazole 20 MG Delayed Release Oral Tablet [Protonix] | SBD | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 284400 | pantoprazole 40 MG Delayed Release Oral Tablet [Protonix] | SBD | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763308 | pantoprazole 40 MG Oral Granules [Protonix] | SBD | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 251872 | pantoprazole 20 MG Delayed Release Oral Tablet | SCD | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 314200 | pantoprazole 40 MG Delayed Release Oral Tablet | SCD | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763306 | pantoprazole 40 MG Oral Granules | SCD | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 251872 | pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 314200 | pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763306 | pantoprazole 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral Granules | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763306 | pantoprazole 40 MG Enteric Coated Oral Granules for Oral Suspension | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 352125 | Protonix 20 MG Delayed Release Oral Tablet | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 284400 | Protonix 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763308 | Protonix 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral Granules | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 284400 | Protonix 40 MG Delayed Release Oral Tablet | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763308 | Protonix 40 MG Enteric Coated Oral Granules for Oral Suspension | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763308 | Protonix 40 MG Oral Granules | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 352125 | Protonx 20 MG (pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0008-0844-01 | 00008084401 | 1 in 1 PACKET | Historical | |||||
| 0008-0844-02 | 00008084402 | 30 PACKET in 1 CARTON (0008-0844-02) / 1 GRANULE, DELAYED RELEASE in 1 PACKET (0008-0844-01) | 30 packet | 2008-02-29 | 0000-00-00 | No | No | Current |