Rabeprazole sodium
- Product NDC
- 13668-107
- 11-digit product format
- 136680107
- Labeler code
- 13668
- Product ID
- 13668-107_4bf4f1c6-0ee4-479e-892c-8956b711374f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rabeprazole sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA202376
- Marketing category
- ANDA
- Marketing start
- 2013-11-08
- Substance
- RABEPRAZOLE SODIUM
- Active strength
- 20 mg/1
- Pharmacologic classes
- 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 |
|---|---|---|---|---|---|---|---|
| A202376-001 | RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202376-001 | 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 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A202376-001 | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE / ORAL | AB | 2013-11-08 | 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 | A202376-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202376-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202376-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202376-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202376-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202376-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202376-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202376-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202376-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202376-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202376-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202376-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202376-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202376-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202376-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A202376-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A202376-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A202376-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A202376-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A202376-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202376-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A202376-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A202376-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A202376-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A202376-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A202376-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A202376-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202376-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A202376-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A202376-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202376-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202376-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202376-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202376-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A202376-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A202376-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202376-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A202376-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A202376-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A202376-001 | AB | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rabeprazole sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| RABEPRAZOLE SODIUM | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3L36P16U4R | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 854868 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 04e88b86-e1dd-4c56-8359-45fbcc161f7d | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4 | Product name | 4 | 20180626 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 9a0b93b8-7081-4ac2-867c-2955b2d759fd | Product name | 2 | 20170909 |
| 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 |
|---|---|---|---|---|---|---|
| 13668-107-30 | Rabeprazole sodium | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | 17 | |
| 13668-107-90 | Rabeprazole sodium | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13668-107-05 | EA - Each | 13668-107 | ecfea035-e2df-499b-8cf0-546aaa388221 | 1 | 2013-12-02 |
| 13668-107-30 | EA - Each | 13668-107 | dbe4e556-87fc-4ffb-9994-9fc9f4c5328a | 1 | 2013-12-02 |
| 13668-107-90 | EA - Each | 13668-107 | 4ec18301-00d6-4fe2-9312-ffa2e35d375c | 1 | 2013-12-02 |
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 |
|---|---|---|---|---|---|---|
| Rabeprazole sodium | RABEPRAZOLE SODIUM | Torrent Pharmaceuticals Limited | 04e88b86-e1dd-4c56-8359-45fbcc161f7d | 2026-07-27 | Warnings, Adverse reactions | 202376 ANDA202376 13668-107 |
| Rabeprazole sodium | RABEPRAZOLE SODIUM | Preferred Pharmaceuticals Inc. | 1855ccab-c377-4962-9225-3c5adc62e2bd | 2025-12-08 | Warnings, Adverse reactions | 202376 ANDA202376 |
| Rabeprazole sodium | RABEPRAZOLE SODIUM | Proficient Rx LP | d1444508-fe40-4f68-8350-52f13399e38a | 2021-01-01 | Warnings, Adverse reactions | 202376 ANDA202376 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 854868 | RABEprazole sodium 20 MG Delayed Release Oral Tablet | PSN | 04e88b86-e1dd-4c56-8359-45fbcc161f7d | 17 |
| 854868 | rabeprazole sodium 20 MG Delayed Release Oral Tablet | SCD | 04e88b86-e1dd-4c56-8359-45fbcc161f7d | 17 |
| 854868 | RABEprazole sodium 20 MG Delayed Release Oral Tablet | PSN | ea013e44-8b21-46c5-bedf-7e956a3b8aa5 | 7 |
| 854868 | rabeprazole sodium 20 MG Delayed Release Oral Tablet | SCD | ea013e44-8b21-46c5-bedf-7e956a3b8aa5 | 7 |
| 854868 | RABEprazole sodium 20 MG Delayed Release Oral Tablet | PSN | 8f896469-4df5-599c-e053-2a95a90ac924 | 6 |
| 854868 | rabeprazole sodium 20 MG Delayed Release Oral Tablet | SCD | 8f896469-4df5-599c-e053-2a95a90ac924 | 6 |
| 854868 | RABEprazole sodium 20 MG Delayed Release Oral Tablet | PSN | d1444508-fe40-4f68-8350-52f13399e38a | 3 |
| 854868 | rabeprazole sodium 20 MG Delayed Release Oral Tablet | SCD | d1444508-fe40-4f68-8350-52f13399e38a | 3 |
| 854868 | RABEprazole sodium 20 MG Delayed Release Oral Tablet | PSN | 1855ccab-c377-4962-9225-3c5adc62e2bd | 1 |
| 854868 | rabeprazole sodium 20 MG Delayed Release Oral Tablet | SCD | 1855ccab-c377-4962-9225-3c5adc62e2bd | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 13668-107-05 | 13668010705 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-107-05) | 2013-11-08 | 0000-00-00 | No | No | Current |
| 13668-107-30 | 13668010730 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-107-30) | 2013-11-08 | 0000-00-00 | No | No | Current |
| 13668-107-40 | 13668010740 | 4000 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-107-40) | 2013-11-08 | 0000-00-00 | No | No | Current |
| 13668-107-74 | 13668010774 | 100 TABLET, DELAYED RELEASE in 1 CARTON (13668-107-74) | 2013-11-08 | 0000-00-00 | No | No | Current |
| 13668-107-90 | 13668010790 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-107-90) | 2013-11-08 | 0000-00-00 | No | No | Current |