Application 091429
- Type
- ANDA
- Sponsor
- PERRIGO R AND D
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 150MG BASE | No | No |
| 002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | TABLET;ORAL | EQ 150MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091429-001 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | ||
| A091429-002 | RANITIDINE HYDROCHLORIDE | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 |
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 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A091429-001 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A091429-002 | RANITIDINE HYDROCHLORIDE | EQ 150MG BASE | TABLET / ORAL | 2011-05-11 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| Ranitidine Hydrochloride | RANITIDINE HYDROCHLORIDE | Dr. Reddy's Laboratories Limited | 7bf94bf7-fa11-70be-9f65-fe26a3db5a63 | 2018-11-21 | Adverse reactions | Ranitidine Hydrochloride RANITIDINE HYDROCHLORIDE |
| Acid Reducer | RANITIDINE HYDROCHLORIDE | WinCo Foods, LLC | 70bc7062-ab3c-43eb-b524-0d8c6d1a674d | 2014-12-10 | Warnings | RANITIDINE HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0113-0852 | Good Sense Acid Reducer | Ranitidine | L. Perrigo Company | ANDA | Current |
| 0113-7852 | basic care acid reducer 150 | Ranitidine | L. Perrigo Company | ANDA | Current |
| 0113-7852 | basic care acid reducer 150 | Ranitidine | L. Perrigo Company | ANDA | Current |
| 0113-7950 | basic care acid reducer | Ranitidine | L. Perrigo Company | ANDA | Current |
| 0363-0852 | wal zan 150 | Ranitidine | Walgreen Company | ANDA | Current |
| 0363-0852 | wal zan 150 | Ranitidine | Walgreen Company | ANDA | Current |
| 0363-0950 | wal zan 150 | Ranitidine | Walgreen Company | ANDA | Current |
| 0904-6716 | Ranitidine | Ranitidine | Major Pharmaceuticals | ANDA | Current |
| 0904-6716 | Ranitidine | Ranitidine | Major Pharmaceuticals | ANDA | Current |
| 10202-852 | 7 Select Acid Reducer | Ranitidine | 7-Eleven | ANDA | Current |
| 10202-852 | 7 Select Acid Reducer | Ranitidine | 7-Eleven | ANDA | Current |
| 11673-023 | up and up ranitidine | Ranitidine | Target Corporation | ANDA | Current |
| 11673-023 | up and up ranitidine | Ranitidine | Target Corporation | ANDA | Current |
| 11673-852 | Up and Up Ranitidine | Ranitidine | Target Corporation | ANDA | Current |
| 11673-852 | Up and Up Ranitidine | Ranitidine | Target Corporation | ANDA | Current |
| 11673-950 | up and up ranitidine 150 | Ranitidine | Target Corporation | ANDA | Current |
| 11673-950 | up and up ranitidine 150 | Ranitidine | Target Corporation | ANDA | Current |
| 11822-0852 | Acid Reducer | Ranitidine | Rite Aid Corporation | ANDA | Current |
| 11822-0852 | Acid Reducer | Ranitidine | Rite Aid Corporation | ANDA | Current |
| 11822-0950 | cool mint acid reducer | Ranitidine | Rite Aid Corporation | ANDA | Current |
| 21130-116 | Signature Care Acid Control | Ranitidine | Safeway | ANDA | Current |
| 21130-116 | Signature Care Acid Control | Ranitidine | Safeway | ANDA | Current |
| 21130-568 | signature care acid control | Ranitidine | Safeway | ANDA | Current |
| 21130-568 | signature care acid control | Ranitidine | Safeway | ANDA | Current |
| 30142-600 | heartburn relief 150 | Ranitidine | Kroger Company | ANDA | Current |
| 30142-600 | heartburn relief 150 | Ranitidine | Kroger Company | ANDA | Current |
| 30142-891 | heartburn relief 150 | Ranitidine | Kroger Company | ANDA | Current |
| 36800-852 | Topcare Heartburn Relief 150 | Ranitidine | Topco Associates LLC | ANDA | Current |
| 36800-852 | Topcare Heartburn Relief 150 | Ranitidine | Topco Associates LLC | ANDA | Current |
| 36800-950 | topcare heartburn relief 150 | Ranitidine | Topco Associates LLC | ANDA | Current |
| 36800-950 | topcare heartburn relief 150 | Ranitidine | Topco Associates LLC | ANDA | Current |
| 37012-852 | Acid Reducer | Ranitidine | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37012-950 | Acid Reducer | Ranitidine | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37808-507 | Acid Reducer | Ranitidine | H E B | ANDA | Current |
| 37808-507 | Acid Reducer | Ranitidine | H E B | ANDA | Current |
| 37808-710 | Acid Reducer | Ranitidine | H E B | ANDA | Current |
| 41163-852 | equaline acid reducer | Ranitidine | Supervalu Inc | ANDA | Current |
| 41163-852 | equaline acid reducer | Ranitidine | Supervalu Inc | ANDA | Current |
| 41163-950 | equaline heartburn relief | Ranitidine | Supervalu Inc | ANDA | Current |
| 41163-950 | equaline heartburn relief | Ranitidine | Supervalu Inc | ANDA | Current |
| 41190-852 | ShopRite Acid Reducer | Ranitidine | Wakefern Food Corporation | ANDA | Current |
| 41190-950 | ShopRite Acid Reducer | Ranitidine | Wakefern Food Corporation | ANDA | Current |
| 41250-577 | Acid Relief | ranitidine | Meijer Distribution Inc | ANDA | Current |
| 41250-577 | Acid Relief | ranitidine | Meijer Distribution Inc | ANDA | Current |
| 41250-852 | acid reducer | Ranitidine | Meijer Distribution Inc | ANDA | Current |
| 41250-852 | acid reducer | Ranitidine | Meijer Distribution Inc | ANDA | Current |
| 41250-891 | acid relief | ranitidine | Meijer Distribution Inc | ANDA | Current |
| 41250-891 | acid relief | ranitidine | Meijer Distribution Inc | ANDA | Current |
| 41250-891 | acid relief | ranitidine | Meijer Distribution Inc | ANDA | Current |
| 41250-891 | acid relief | ranitidine | Meijer Distribution Inc | ANDA | Current |
| 41250-950 | acid reducer | Ranitidine | Meijer Distribution Inc | ANDA | Current |
| 41250-950 | acid reducer | Ranitidine | Meijer Distribution Inc | ANDA | Current |
| 41520-392 | CareOne Acid Relief | Ranitidine | American Sales Company | ANDA | Current |
| 41520-392 | CareOne Acid Relief | Ranitidine | American Sales Company | ANDA | Current |
| 41520-609 | CareOne Acid Relief | Ranitidine | American Sales Company | ANDA | Current |
| 41520-609 | CareOne Acid Relief | Ranitidine | American Sales Company | ANDA | Current |
| 41520-852 | careone acid reducer | Ranitidine | American Sales Company | ANDA | Current |
| 46122-041 | good neighbor pharmacy acid control 150 | Ranitidine | Amerisource Bergen | ANDA | Current |
| 46122-041 | good neighbor pharmacy acid control 150 | Ranitidine | Amerisource Bergen | ANDA | Current |
| 46122-041 | good neighbor pharmacy acid control 150 | Ranitidine | Amerisource Bergen | ANDA | Current |
| 46122-224 | Good Neighbor Pharmacy Acid Control 150 | Ranitidine | Amerisource Bergen | ANDA | Current |
| 46122-224 | Good Neighbor Pharmacy Acid Control 150 | Ranitidine | Amerisource Bergen | ANDA | Current |
| 46122-532 | Good Neighbor Pharmacy acid control | Ranitidine | Amerisource Bergen | ANDA | Current |
| 46122-533 | good neighbor pharmacy acid control | Ranitidine | Amerisource Bergen | ANDA | Current |
| 46994-852 | Being Well Heartburn Relief | Ranitidine | Save-A-Lot Food Stores Ltd | ANDA | Current |
| 49035-608 | Equate Ranitidine | Ranitidine | Wal-Mart Stores Inc | ANDA | Current |
| 49035-608 | Equate Ranitidine | Ranitidine | Wal-Mart Stores Inc | ANDA | Current |
| 49035-800 | Equate Ranitidine Acid Reducer | Ranitidine | Wal-Mart Stores Inc | ANDA | Current |
| 49035-852 | equate acid reducer | Ranitidine | Wal-Mart Stores Inc | ANDA | Current |
| 49348-109 | Sunmark acid reducer | Ranitidine | Strategic Sourcing Services LLC | ANDA | Current |
| 49348-109 | Sunmark acid reducer | Ranitidine | Strategic Sourcing Services LLC | ANDA | Current |
| 49348-109 | Sunmark acid reducer | Ranitidine | Mckesson | ANDA | Current |
| 49738-361 | smart sense ranitidine | Ranitidine | Kmart Corporation | ANDA | Current |
| 49738-471 | Smart Sense Ranitidine | Ranitidine | Kmart Corporation | ANDA | Current |
| 49781-051 | Leader Acid Control | Ranitidine | Cardinal Health | ANDA | Current |
| 49781-079 | Leader Acid Control | Ranitidine | Cardinal Health | ANDA | Current |
| 50594-852 | sound body acid reducer 150 | Ranitidine | Big Lots Stores, Inc. | ANDA | Current |
| 50594-852 | sound body acid reducer 150 | Ranitidine | Big Lots Stores, Inc. | ANDA | Current |
| 55301-852 | Exchange Select Acid Reducer | Ranitidine | Army & Air Force Exchange Service | ANDA | Current |
| 55301-852 | Exchange Select Acid Reducer | Ranitidine | Army & Air Force Exchange Service | ANDA | Current |