Application 019510
- Type
- NDA
- Sponsor
- MERCK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PEPCID | FAMOTIDINE | INJECTABLE;INJECTION | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | PEPCID PRESERVATIVE FREE | FAMOTIDINE | INJECTABLE;INJECTION | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019510-001 | PEPCID | FAMOTIDINE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | |
| N019510-004 | PEPCID PRESERVATIVE FREE | FAMOTIDINE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 |
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| 2026-08 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019510-001 | PEPCID | 10MG/ML | INJECTABLE / INJECTION | RLD | 1986-11-04 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML | INJECTABLE / INJECTION | RLD | 1986-11-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019510-001 | PEPCID | 10MG/ML | INJECTABLE / INJECTION | RLD | 1986-11-04 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML | INJECTABLE / INJECTION | RLD | 1986-11-04 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 74a2ff9319b5… |
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 | Redpharm Drug | 44f3f63d-4522-91e4-e063-6394a90a6d1b | 2025-12-02 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Ajanta Pharma USA Inc. | a88e7069-230c-4105-ade0-a98968e18671 | 2025-11-30 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Novadoz Pharmaceuticals LLC | 74a24590-a0b6-4607-8e67-9fadce53389b | 2025-11-12 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | AvPAK | 85c7d20d-3dec-b918-4c1d-8ca1db214e48 | 2025-11-11 | Warnings, Adverse reactions | FAMOTIDINE |
| famotidine | FAMOTIDINE | Chartwell RX, LLC | 70714491-1368-4824-98af-03fda52139a9 | 2025-11-04 | Warnings, Adverse reactions | FAMOTIDINE |
| Heartburn Relief | FAMOTIDINE | Shield Pharmaceuticals Corp | a12ec91d-244f-45c5-8590-d1e4485fe361 | 2025-10-31 | Warnings | FAMOTIDINE |
| careone acid relief | FAMOTIDINE | Retail Business Services, LLC | 8f654234-b25d-47d6-b1f8-f7f353569795 | 2025-10-30 | Warnings | FAMOTIDINE |
| Acid Controller | FAMOTIDINE | H E B | 8aac5a0d-074b-4cf4-ab10-549e1ed09e2f | 2025-10-30 | Warnings | FAMOTIDINE |
| FAMOTIDINE | FAMOTIDINE | Bryant Ranch Prepack | 7cef62ab-1740-4d0f-b6ea-fda783e1c197 | 2025-10-23 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | PD-Rx Pharmaceuticals, Inc. | 002875d2-8c30-2d2e-e063-6294a90ae01e | 2025-10-22 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | PD-Rx Pharmaceuticals, Inc. | 66f0bf15-ff35-426a-b40c-0d0da79d0861 | 2025-10-16 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | PD-Rx Pharmaceuticals, Inc. | 09ef39a4-c6b3-4395-8211-3f551dc44830 | 2025-10-16 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | PD-Rx Pharmaceuticals, Inc. | 5798d282-ce83-49aa-bc33-13203f2b5285 | 2025-10-15 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | PD-Rx Pharmaceuticals, Inc. | 2f5ec69d-926c-47a2-be47-8fef2e0ff207 | 2025-10-14 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Bryant Ranch Prepack | c133a9e1-ca48-4ee2-8768-01f44f5dd511 | 2025-10-14 | Warnings, Adverse reactions | FAMOTIDINE |
| FAMOTIDINE | FAMOTIDINE | A-S Medication Solutions | 3c32f8e2-f54a-422d-9c25-68692ea09001 | 2025-10-10 | Warnings, Adverse reactions | FAMOTIDINE |
| FAMOTIDINE | FAMOTIDINE | PD-Rx Pharmaceuticals, Inc. | a3b50576-cd40-4f7e-9506-bd0a61988424 | 2025-10-09 | Warnings, Adverse reactions | FAMOTIDINE |
| Zantac 360 Cool Mint | FAMOTIDINE | Chattem, Inc. | 19fe7c6e-243c-4005-a63a-f8cac1ce55c8 | 2025-09-30 | Warnings | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Bryant Ranch Prepack | e034546b-28cb-41aa-9441-655cdb966554 | 2025-09-29 | Warnings, Adverse reactions | FAMOTIDINE |
| equaline heartburn prevention | FAMOTIDINE | United Natural Foods, Inc. dba UNFI | f40f1dcf-249a-4ccb-bdfc-acff49dd4a15 | 2025-09-25 | Warnings | FAMOTIDINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.