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| FAMOTIDINE | INJECTABLE;INJECTION | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| FAMOTIDINE | INJECTABLE;INJECTION | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| N019510-001 | PEPCID | FAMOTIDINE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | |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| PEPCID PRESERVATIVE FREE | FAMOTIDINE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 |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| 2026-08 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 84e616aacf4f… | |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N019510-004 | PEPCID PRESERVATIVE FREE | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | 84e616aacf4f… | |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| 2026-07 | N019510-001 | PEPCID | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1986-11-04 | caaa826d4ba7… | |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 |
|---|---|---|---|---|---|---|
| Equate Famotidine | FAMOTIDINE | Wal-Mart Stores Inc | 8ac94821-aa78-4e57-bc9a-f1f2a0e47b07 | 2026-03-03 | Warnings | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Proficient Rx LP | d60bde93-f512-4071-9e4b-1d8318def3bc | 2026-03-01 | Warnings, Adverse reactions | FAMOTIDINE |
| acid controller | FAMOTIDINE | Walgreen Company | c16d9977-39ad-4386-8867-72aab97c99d5 | 2026-02-28 | Warnings | FAMOTIDINE |
| berkley and jensen famotidine | FAMOTIDINE | BJWC | 93c857e4-72b3-433e-ae6f-281cd57e3996 | 2026-02-17 | Warnings | FAMOTIDINE |
| heartburn relief original strength | FAMOTIDINE | Major Pharmaceuticals | be275c48-18bf-45f6-891d-36d89327813e | 2026-02-13 | Warnings | FAMOTIDINE |
| Pepcid AC Original Strength | FAMOTIDINE | Kenvue Brands LLC | 54f4086f-e443-4e7e-8c7e-94e152e1c256 | 2026-02-06 | Warnings | FAMOTIDINE |
| acid reducer | FAMOTIDINE | H E B | 140f0e60-c809-4d86-a750-7649ee2881b5 | 2026-02-03 | Warnings | FAMOTIDINE |
| Famotidine | FAMOTIDINE | GLENMARK THERAPEUTICS INC., USA | 95f51f27-d367-4cfd-a15f-7856c9e361fb | 2026-01-13 | Warnings | FAMOTIDINE |
| FAMOTIDINE | FAMOTIDINE | Aurobindo Pharma Limited | 18066b80-1ec6-4092-80d9-70adb0ecac85 | 2026-01-09 | Warnings, Adverse reactions | FAMOTIDINE |
| FAMOTIDINE | FAMOTIDINE | Bryant Ranch Prepack | 900b4fd6-9c62-4b64-b4db-760c49ae0a42 | 2026-01-09 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Alembic Pharmaceuticals Inc. | f149ecc1-d66c-42f9-a3f4-2ab6a522942b | 2026-01-09 | Warnings, Adverse reactions | FAMOTIDINE |
| acid relief | FAMOTIDINE | Rite Aid Corporation | 45789b7a-e9c7-4813-b07b-f88d9108455d | 2026-01-06 | Warnings | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Northwind Health Company, LLC | f2b6da72-72ea-d81b-e053-2995a90a9526 | 2026-01-01 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Northwind Health Company, LLC | ab1cdbbf-d838-020c-e053-2995a90a0f65 | 2026-01-01 | Warnings, Adverse reactions | FAMOTIDINE |
| FAMOTIDINE | FAMOTIDINE | A-S Medication Solutions | 74a69baa-a7c5-4e67-8db6-2ec39ab6cfe5 | 2025-12-30 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Northwind Health Company, LLC | 43454e0f-4e1e-bbc6-e063-6394a90a5ac4 | 2025-12-29 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Lupin Pharmaceuticals, Inc. | 2caaf94b-b382-4573-8614-57815776b659 | 2025-12-29 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Northwind Health Company, LLC | 03503cd5-bd8e-4bff-b90d-1a71c5225b91 | 2025-12-26 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Redpharm Drug | 37361ccf-e080-d58e-e063-6394a90ab92e | 2025-12-24 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | SAFEWAY | f18c1195-48a1-69dc-e053-2a95a90a4077 | 2025-12-18 | Warnings | FAMOTIDINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.