Application 019462
- Type
- NDA
- Sponsor
- VALEANT PHARMS NORTH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PEPCID | FAMOTIDINE | TABLET;ORAL | 20MG | Yes | No |
| 002 | PEPCID | FAMOTIDINE | TABLET;ORAL | 40MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019462-001 | PEPCID | FAMOTIDINE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | |
| N019462-002 | PEPCID | FAMOTIDINE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N019462-001 | PEPCID | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019462-002 | PEPCID | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019462-001 | PEPCID | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019462-002 | PEPCID | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019462-001 | PEPCID | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019462-002 | PEPCID | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019462-001 | PEPCID | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019462-002 | PEPCID | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019462-001 | PEPCID | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019462-002 | PEPCID | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019462-001 | PEPCID | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019462-002 | PEPCID | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019462-001 | PEPCID | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019462-002 | PEPCID | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019462-001 | PEPCID | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019462-002 | PEPCID | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019462-001 | PEPCID | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019462-002 | PEPCID | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019462-001 | PEPCID | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019462-002 | PEPCID | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019462-001 | PEPCID | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019462-002 | PEPCID | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019462-001 | PEPCID | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019462-002 | PEPCID | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019462-001 | PEPCID | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019462-002 | PEPCID | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019462-001 | PEPCID | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019462-002 | PEPCID | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019462-001 | PEPCID | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019462-002 | PEPCID | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019462-001 | PEPCID | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019462-002 | PEPCID | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019462-001 | PEPCID | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019462-002 | PEPCID | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-10-15 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019462-001 | PEPCID | 20MG | TABLET / ORAL | RLD | 1986-10-15 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019462-002 | PEPCID | 40MG | TABLET / ORAL | RLD | 1986-10-15 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019462-001 | PEPCID | 20MG | TABLET / ORAL | RLD | 1986-10-15 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019462-002 | PEPCID | 40MG | TABLET / ORAL | RLD | 1986-10-15 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019462-001 | PEPCID | 20MG | TABLET / ORAL | AB | RLD | 1986-10-15 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019462-002 | PEPCID | 40MG | TABLET / ORAL | AB | RLD, RS | 1986-10-15 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N019462-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N019462-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N019462-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N019462-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N019462-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N019462-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N019462-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N019462-002 | AB | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Famotidine | FAMOTIDINE | Bryant Ranch Prepack | db3af7cc-efc6-4934-acff-8bb2d31fe829 | 2026-05-19 | Warnings, Adverse reactions | FAMOTIDINE |
| good sense acid reducer | FAMOTIDINE | L. Perrigo Company | cc77f6ff-a534-4731-b971-491280840899 | 2026-05-18 | Warnings | FAMOTIDINE |
| Good Sense Acid Reducer | FAMOTIDINE | L. Perrigo Company | 39cb0f15-d177-46eb-a549-7acb885fbf07 | 2026-05-11 | Warnings | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Cardinal Health 107, LLC | 5d515c2a-dac9-42d8-aede-66d28a427dbc | 2026-05-11 | Warnings, Adverse reactions | FAMOTIDINE |
| FAMOTIDINE | FAMOTIDINE | ST. MARY'S MEDICAL PARK PHARMACY | febe39b1-9212-a281-e053-6394a90a1a9f | 2026-05-01 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Cardinal Health 107, LLC | cdd5dfb7-4efb-4235-8023-5ce145c09038 | 2026-04-27 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | REMEDYREPACK INC. | 8dbf43e0-856f-443b-b8a4-c69e006878ea | 2026-04-24 | Warnings, Adverse reactions | FAMOTIDINE |
| Acid Controller | FAMOTIDINE | Walgreen Company | 42392cb1-7958-4a2f-8622-f00f02afd961 | 2026-04-24 | Warnings | FAMOTIDINE |
| FAMOTIDINE | FAMOTIDINE | Preferred Pharmaceuticals Inc. | b445a613-eaa8-45e8-be1f-5848bfd1dd36 | 2026-04-15 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Preferred Pharmaceuticals, Inc. | b1edf3c5-e42c-471b-8771-6c93094822de | 2026-04-15 | Warnings, Adverse reactions | FAMOTIDINE |
| FAMOTIDINE | FAMOTIDINE | Preferred Pharmaceuticals Inc. | dbf94314-3a34-4f03-80b1-296559b7d6a5 | 2026-04-15 | Warnings, Adverse reactions | FAMOTIDINE |
| acid controller | FAMOTIDINE | CVS Pharmacy | 1531aa51-02e9-45ed-99aa-53b21732dd2e | 2026-04-06 | Warnings | FAMOTIDINE |
| FAMOTIDINE | FAMOTIDINE | REMEDYREPACK INC. | 3ab235f4-da59-4a92-ad6b-c76cf3ecd985 | 2026-04-02 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Medical Purchasing Solutions, LLC | 4e803491-8030-50d0-e063-6294a90a5c8d | 2026-04-02 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Bryant Ranch Prepack | 545d5c1f-ec1c-4135-965f-333ad888d96f | 2026-03-31 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Preferred Pharmaceuticals Inc. | fd5d15b9-b1b5-48ef-ba41-8a43a7642e94 | 2026-03-17 | Warnings, Adverse reactions | FAMOTIDINE |
| acid reducer original strength | FAMOTIDINE | HyVee Inc | a0f2683f-59ad-4f65-a108-696430d577ab | 2026-03-16 | Warnings | FAMOTIDINE |
| ACID REDUCER | FAMOTIDINE | Publix Super Markets Inc | 3455be3c-696e-402a-a5df-830544fa525a | 2026-03-11 | Warnings | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Legacy Pharmaceutical Packaging, LLC | cc88fbdc-546e-332f-e053-2995a90a8ca7 | 2026-03-03 | Warnings, Adverse reactions | FAMOTIDINE |
| Acid Controller Original Strength | FAMOTIDINE | Walgreen Company | 98c6ddc9-8103-40b3-a145-ffbe3374ab6c | 2026-03-03 | Warnings | FAMOTIDINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56427 | SUPPL | 2018-11-23 |
| 56447 | SUPPL | 2018-11-15 |
| 54697 | SUPPL | 2018-06-27 |
| 54662 | SUPPL | 2018-06-21 |
| 17411 | SUPPL | 2014-02-10 |
| 33754 | SUPPL | 2014-02-06 |
| 33753 | SUPPL | 2011-06-07 |
| 1333 | SUPPL | 2011-06-03 |
| 33752 | SUPPL | 2010-03-26 |
| 1332 | SUPPL | 2010-03-25 |
| 17410 | SUPPL | 2007-11-08 |
| 11510 | SUPPL | 2007-11-07 |
| 20246 | SUPPL | 2007-07-09 |
| 11508 | ORIG | 2003-04-30 |
| 33751 | SUPPL | 2003-04-24 |
| 17409 | SUPPL | 2002-06-06 |
| 11509 | SUPPL | 2002-06-06 |
| 1331 | SUPPL | 2001-03-14 |
| 20245 | SUPPL | 1999-03-18 |
| 57456 | ORIG | 1986-10-15 |