Pantoprazole Sodium
- Product NDC
- 65862-559
- 11-digit product format
- 658620559
- Labeler code
- 65862
- Product ID
- 65862-559_4784124c-9df4-42f6-8044-c0480c1a3bbf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pantoprazole Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA202038
- Marketing category
- ANDA
- Marketing start
- 2012-09-28
- Substance
- PANTOPRAZOLE SODIUM
- Active strength
- 20 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| unfinished product | product | 65862-559 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-03 | ||
| unfinished package | package | 65862-559 | 65862-559-55 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished product | product | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 65862-559-55 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished product | product | 1d862106b807… | 00c93037cd84… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 65862-559-55 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished product | product | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 65862-559-55 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | e30019b0c005… | a3f0b14938b7… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 65862-559-55 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 65862-559-55 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 65862-559-55 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | f764e8902f78… | 92046438deef… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 65862-559-55 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 65862-559-55 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished product | product | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 65862-559-55 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished product | product | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 65862-559-55 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished product | product | 27f29a85d7e4… | 1372111e901f… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 65862-559-55 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished product | product | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 65862-559-55 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished product | product | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 65862-559-55 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished product | product | 50b4072663b7… | eae3003ed65e… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 65862-559-55 | 50b4072663b7… | eae3003ed65e… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished product | product | 906f6e251498… | bf70b80e44f0… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished package | package | 65862-559-55 | 906f6e251498… | bf70b80e44f0… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished product | product | 6db9cb8d1e19… | 3449e1ec5b70… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished package | package | 65862-559-55 | 6db9cb8d1e19… | 3449e1ec5b70… |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished product | product | 8fc7167e32ce… | e96bbc724034… | |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished package | package | 65862-559-55 | 8fc7167e32ce… | e96bbc724034… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished product | product | 4184dd79f89f… | 545327b3e20f… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished package | package | 65862-559-55 | 4184dd79f89f… | 545327b3e20f… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished product | product | 4bd3596a7b87… | 5c64c6f6865f… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished package | package | 65862-559-55 | 4bd3596a7b87… | 5c64c6f6865f… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished product | product | 263afe128892… | 91768de4ddbe… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished package | package | 65862-559-55 | 263afe128892… | 91768de4ddbe… |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished product | product | 5b2001dcd8f5… | 54b53d4dc9e4… | |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished package | package | 65862-559-55 | 5b2001dcd8f5… | 54b53d4dc9e4… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202038-001 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | |
| A202038-002 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202038-001 | AB |
| A202038-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A202038-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A202038-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2012-09-28 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202038-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202038-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202038-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202038-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202038-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202038-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202038-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202038-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202038-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202038-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202038-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202038-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202038-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202038-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202038-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202038-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202038-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202038-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202038-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202038-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202038-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202038-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202038-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202038-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202038-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202038-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202038-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A202038-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202038-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202038-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A202038-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A202038-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A202038-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202038-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A202038-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202038-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A202038-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202038-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A202038-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202038-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pantoprazole Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PANTOPRAZOLE SODIUM | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6871619Q5X | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7418f358-f536-4de6-adf0-562b4373f2e3 | 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 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65862-559-10 | Pantoprazole Sodium | 10 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 10 | 24 | |
| 65862-559-10 | Pantoprazole Sodium | 10 in 1 CARTON | TABLET, DELAYED RELEASE | 10 | 24 | |
| 65862-559-90 | Pantoprazole Sodium | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | 24 | |
| 65862-559-99 | Pantoprazole Sodium | 1000 in 1 BOTTLE | TABLET, DELAYED RELEASE | 1000 | 24 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-559-90 | EA - Each | 65862-559 | 83395f2b-8057-4b28-9e21-e022588d0322 | 1 | 2013-06-04 |
| 65862-559-99 | EA - Each | 65862-559 | a4b3ea75-b090-4d0f-901d-e4ca41c0ffdf | 1 | 2013-06-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | REMEDYREPACK INC. | 76e1839b-7462-4344-b319-001a5f57d67a | 2026-07-14 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | REMEDYREPACK INC. | f38a6df2-1dd4-48bf-9ec4-1113ce492e78 | 2026-07-03 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Unit Dose Solutions, Inc. | 558dc7e1-dfd5-d3d7-e063-6394a90ab9c3 | 2026-07-01 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | REMEDYREPACK INC. | f313159c-115a-4cf6-b32e-9ddc833fd51c | 2026-07-01 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Unit Dose Solutions, Inc. | 5566b4b1-b4f5-4020-e063-6394a90a5257 | 2026-06-29 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | HAWAII REPACK, INC. | f403c94d-68b7-43df-8c8e-c9fef3309cfc | 2026-06-26 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Bryant Ranch Prepack | 03dea010-4bae-43ab-893e-9bbddb58062d | 2026-06-05 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Coupler LLC | 5331f534-4724-52e8-e063-6394a90aa548 | 2026-06-01 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Coupler LLC | 52bbab54-9f11-77bc-e063-6394a90ab449 | 2026-05-26 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Bryant Ranch Prepack | 9a1159d3-b9fa-4026-962c-d3001002e610 | 2026-05-19 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | QPharma Inc | 0e200326-8885-18d0-e063-6294a90aad2f | 2026-05-11 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Aurobindo Pharma Limited | 7418f358-f536-4de6-adf0-562b4373f2e3 | 2026-02-06 | Warnings, Adverse reactions | 202038 ANDA202038 65862-559 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | NorthStar Rx LLC | 6637d90b-b268-4a5f-ab5b-885f2d5f0d4b | 2026-02-06 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Burel Pharmaceuticals, LLC | 3cc5197e-6b39-4415-b963-d4bbeecd7953 | 2026-02-06 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Cardinal Health 107, LLC | 6229247e-ee15-466e-a8ac-adcd646b738d | 2026-01-22 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Major Pharmaceuticals | de419aa0-caa9-40fb-bc6d-e341c94273c7 | 2026-01-08 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Northwind Health Company, LLC | f2a1af50-a051-3e55-e053-2a95a90a9184 | 2026-01-01 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Northwind Health Company, LLC | d9deb251-96d3-5f96-e053-2a95a90a0792 | 2026-01-01 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | NuCare Pharmaceuticals,Inc. | 8aac1642-6cb0-6ad2-e053-2a95a90a4cbd | 2025-01-31 | Warnings, Adverse reactions | 202038 ANDA202038 |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Quality Care Products, LLC | a9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e2 | 2024-12-19 | Warnings, Adverse reactions | 202038 ANDA202038 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 251872 | pantoprazole sodium 20 MG Delayed Release Oral Tablet | PSN | 03dea010-4bae-43ab-893e-9bbddb58062d | 102 |
| 251872 | pantoprazole 20 MG Delayed Release Oral Tablet | SCD | 03dea010-4bae-43ab-893e-9bbddb58062d | 102 |
| 251872 | pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | 03dea010-4bae-43ab-893e-9bbddb58062d | 102 |
| 251872 | pantoprazole sodium 20 MG Delayed Release Oral Tablet | PSN | 7418f358-f536-4de6-adf0-562b4373f2e3 | 24 |
| 314200 | pantoprazole sodium 40 MG Delayed Release Oral Tablet | PSN | 7418f358-f536-4de6-adf0-562b4373f2e3 | 24 |
| 251872 | pantoprazole 20 MG Delayed Release Oral Tablet | SCD | 7418f358-f536-4de6-adf0-562b4373f2e3 | 24 |
| 314200 | pantoprazole 40 MG Delayed Release Oral Tablet | SCD | 7418f358-f536-4de6-adf0-562b4373f2e3 | 24 |
| 251872 | pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | 7418f358-f536-4de6-adf0-562b4373f2e3 | 24 |
| 314200 | pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet | SY | 7418f358-f536-4de6-adf0-562b4373f2e3 | 24 |
| 251872 | pantoprazole sodium 20 MG Delayed Release Oral Tablet | PSN | 76e1839b-7462-4344-b319-001a5f57d67a | 20 |
| 251872 | pantoprazole 20 MG Delayed Release Oral Tablet | SCD | 76e1839b-7462-4344-b319-001a5f57d67a | 20 |
| 251872 | pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | 76e1839b-7462-4344-b319-001a5f57d67a | 20 |
| 251872 | pantoprazole sodium 20 MG Delayed Release Oral Tablet | PSN | 517d6b02-0e68-4d6b-98b3-eac0be457e6b | 9 |
| 251872 | pantoprazole 20 MG Delayed Release Oral Tablet | SCD | 517d6b02-0e68-4d6b-98b3-eac0be457e6b | 9 |
| 251872 | pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | 517d6b02-0e68-4d6b-98b3-eac0be457e6b | 9 |
| 251872 | pantoprazole sodium 20 MG Delayed Release Oral Tablet | PSN | 1680b4ed-d5b0-4fd9-b1d1-04df6a2138be | 8 |
| 251872 | pantoprazole 20 MG Delayed Release Oral Tablet | SCD | 1680b4ed-d5b0-4fd9-b1d1-04df6a2138be | 8 |
| 251872 | pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | 1680b4ed-d5b0-4fd9-b1d1-04df6a2138be | 8 |
| 251872 | pantoprazole sodium 20 MG Delayed Release Oral Tablet | PSN | de419aa0-caa9-40fb-bc6d-e341c94273c7 | 6 |
| 314200 | pantoprazole sodium 40 MG Delayed Release Oral Tablet | PSN | de419aa0-caa9-40fb-bc6d-e341c94273c7 | 6 |
| 251872 | pantoprazole 20 MG Delayed Release Oral Tablet | SCD | de419aa0-caa9-40fb-bc6d-e341c94273c7 | 6 |
| 314200 | pantoprazole 40 MG Delayed Release Oral Tablet | SCD | de419aa0-caa9-40fb-bc6d-e341c94273c7 | 6 |
| 251872 | pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | de419aa0-caa9-40fb-bc6d-e341c94273c7 | 6 |
| 314200 | pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet | SY | de419aa0-caa9-40fb-bc6d-e341c94273c7 | 6 |
| 251872 | pantoprazole sodium 20 MG Delayed Release Oral Tablet | PSN | f2a1af50-a051-3e55-e053-2a95a90a9184 | 4 |
| 251872 | pantoprazole sodium 20 MG Delayed Release Oral Tablet | PSN | 924a80b9-de48-90c0-e053-2995a90a00e1 | 4 |
| 251872 | pantoprazole 20 MG Delayed Release Oral Tablet | SCD | f2a1af50-a051-3e55-e053-2a95a90a9184 | 4 |
| 251872 | pantoprazole 20 MG Delayed Release Oral Tablet | SCD | 924a80b9-de48-90c0-e053-2995a90a00e1 | 4 |
| 251872 | pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | f2a1af50-a051-3e55-e053-2a95a90a9184 | 4 |
| 251872 | pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | 924a80b9-de48-90c0-e053-2995a90a00e1 | 4 |
| 251872 | pantoprazole sodium 20 MG Delayed Release Oral Tablet | PSN | a9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e2 | 3 |
| 251872 | pantoprazole 20 MG Delayed Release Oral Tablet | SCD | a9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e2 | 3 |
| 251872 | pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | a9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e2 | 3 |
| 251872 | pantoprazole sodium 20 MG Delayed Release Oral Tablet | PSN | 5ff3cf6c-6f0a-4374-8b80-4e1eb1df6245 | 2 |
| 314200 | pantoprazole sodium 40 MG Delayed Release Oral Tablet | PSN | 5ff3cf6c-6f0a-4374-8b80-4e1eb1df6245 | 2 |
| 251872 | pantoprazole 20 MG Delayed Release Oral Tablet | SCD | 5ff3cf6c-6f0a-4374-8b80-4e1eb1df6245 | 2 |
| 314200 | pantoprazole 40 MG Delayed Release Oral Tablet | SCD | 5ff3cf6c-6f0a-4374-8b80-4e1eb1df6245 | 2 |
| 251872 | pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | 5ff3cf6c-6f0a-4374-8b80-4e1eb1df6245 | 2 |
| 314200 | pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet | SY | 5ff3cf6c-6f0a-4374-8b80-4e1eb1df6245 | 2 |
| 251872 | pantoprazole sodium 20 MG Delayed Release Oral Tablet | PSN | 138b30cb-6b28-450e-9e7a-42576cc76545 | 1 |
| 251872 | pantoprazole sodium 20 MG Delayed Release Oral Tablet | PSN | 1c46140c-2399-5ca3-e063-6394a90af33b | 1 |
| 251872 | pantoprazole sodium 20 MG Delayed Release Oral Tablet | PSN | f92276a1-b286-489d-a372-f441e49cfd63 | 1 |
| 314200 | pantoprazole sodium 40 MG Delayed Release Oral Tablet | PSN | 138b30cb-6b28-450e-9e7a-42576cc76545 | 1 |
| 251872 | pantoprazole 20 MG Delayed Release Oral Tablet | SCD | 138b30cb-6b28-450e-9e7a-42576cc76545 | 1 |
| 251872 | pantoprazole 20 MG Delayed Release Oral Tablet | SCD | f92276a1-b286-489d-a372-f441e49cfd63 | 1 |
| 251872 | pantoprazole 20 MG Delayed Release Oral Tablet | SCD | 1c46140c-2399-5ca3-e063-6394a90af33b | 1 |
| 314200 | pantoprazole 40 MG Delayed Release Oral Tablet | SCD | 138b30cb-6b28-450e-9e7a-42576cc76545 | 1 |
| 251872 | pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | 138b30cb-6b28-450e-9e7a-42576cc76545 | 1 |
| 251872 | pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | 1c46140c-2399-5ca3-e063-6394a90af33b | 1 |
| 251872 | pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | f92276a1-b286-489d-a372-f441e49cfd63 | 1 |
| 314200 | pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet | SY | 138b30cb-6b28-450e-9e7a-42576cc76545 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65862-559-10 | 65862055910 | 10 BLISTER PACK in 1 CARTON (65862-559-10) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 10 blister pack | 2012-09-28 | 0000-00-00 | No | No | Current |
| 65862-559-55 | 65862055955 | 15000 TABLET, DELAYED RELEASE in 1 BAG (65862-559-55) | 28-SEP-12 | Current | ||||
| 65862-559-90 | 65862055990 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-559-90) | 2012-09-28 | 0000-00-00 | No | No | Current | |
| 65862-559-99 | 65862055999 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-559-99) | 2012-09-28 | 0000-00-00 | No | No | Current |