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| FAMOTIDINE | INJECTABLE;INJECTION | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| FAMOTIDINE | INJECTABLE;INJECTION | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| N019510-001 | PEPCID | FAMOTIDINE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | |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| PEPCID PRESERVATIVE FREE | FAMOTIDINE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 |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| 2026-08 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 84e616aacf4f… | |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N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 84e616aacf4f… | |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| 2026-07 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | caaa826d4ba7… | |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 | Aphena Pharma Solutions - Tennessee, LLC | 46c6d243-eefc-40ca-8bd4-4c89456f635f | 2021-05-18 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | BluePoint Laboratories | 8c7ca3cc-ff90-42a7-9218-554cf15348a3 | 2021-04-13 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Dr.Reddy's Laboratories Limited | 06d286ce-14b3-4b66-8b42-ac4a10a0fc90 | 2020-11-17 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Aphena Pharma Solutions - Tennessee, LLC | b1839d23-20f4-4651-a7d2-8bc3a7583917 | 2020-07-06 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Proficient Rx LP | 1e2003d4-09a3-4cc8-af3d-93d29b9123c0 | 2020-07-01 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Proficient Rx LP | 92048836-e692-4ce1-93f4-88b00acabcde | 2019-11-01 | Adverse reactions | FAMOTIDINE |
| heartburn relief original strength | FAMOTIDINE | Proficient Rx LP | 5567aaaf-b4f2-4604-b841-c9447e77256c | 2019-10-01 | Warnings | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Teva Pharmaceuticals USA, Inc. | 4c6f4f9e-f3f5-4ecf-9f40-887e037e8847 | 2019-01-01 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Lupin Pharmaceuticals,Inc. | a0bdf4d1-8458-4e4f-95aa-bcc38c0f32f8 | 2017-11-21 | Adverse reactions | FAMOTIDINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.