Application 019527
- Type
- NDA
- Sponsor
- SALIX PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PEPCID | FAMOTIDINE | FOR SUSPENSION;ORAL | 40MG/5ML | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019527-001 | PEPCID | FAMOTIDINE | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 |
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| 2026-08 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019527-001 | PEPCID | 40MG/5ML | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019527-001 | PEPCID | 40MG/5ML | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019527-001 | PEPCID | 40MG/5ML | FOR SUSPENSION / ORAL | AB | RLD, RS | 1987-02-02 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N019527-001 | PEPCID | 40MG/5ML | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019527-001 | PEPCID | 40MG/5ML | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019527-001 | PEPCID | 40MG/5ML | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019527-001 | PEPCID | 40MG/5ML | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N019527-001 | PEPCID | 40MG/5ML | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N019527-001 | PEPCID | 40MG/5ML | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N019527-001 | PEPCID | 40MG/5ML | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N019527-001 | PEPCID | 40MG/5ML | FOR SUSPENSION / ORAL | AB | RLD, RS | 1987-02-02 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N019527-001 | PEPCID | 40MG/5ML | FOR SUSPENSION / ORAL | AB | RLD, RS | 1987-02-02 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N019527-001 | PEPCID | 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1987-02-02 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N019527-001 | AB | 1 | 74a2ff9319b5… |
| 2019-09-15 20:21 UTC | 2019-09 | N019527-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N019527-001 | 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 | NuCare Pharmaceuticals,Inc. | fd271deb-c748-bf26-e053-6294a90a11aa | 2024-06-28 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | NuCare Pharmaceuticals,Inc. | 60cd0973-f74e-2b70-e053-2a91aa0a4361 | 2024-06-06 | Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | A-S Medication Solutions | 0abfc8e6-7fdf-4828-89f4-2202002f8489 | 2024-06-03 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | A-S Medication Solutions | 75a334ee-48b9-47e7-8225-6e595bed8a74 | 2024-06-03 | Warnings, Adverse reactions | FAMOTIDINE |
| Pepcid | FAMOTIDINE | Bausch Health US LLC | a06502d9-7903-4f37-833e-e5763d502def | 2024-06-01 | Warnings, Adverse reactions | Pepcid FAMOTIDINE |
| Famotidine | FAMOTIDINE | Rising Pharma Holdings, Inc. | 15b87f7f-1abf-4d8a-bdbe-03bea0021a68 | 2024-05-29 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | VKT Pharma Private Limited | 1c2cfb3c-eaa0-403f-9589-d706afc06f51 | 2024-05-22 | Warnings | FAMOTIDINE |
| Maximum Strength Acid Reducer | FAMOTIDINE | TARGET CORPORATION | 07a924f1-14cc-4e7d-e063-6394a90ac7f3 | 2024-05-13 | Warnings | FAMOTIDINE |
| Zantac 360 | FAMOTIDINE | Navajo Manufacturing Company Inc. | e328c59c-baed-0e4e-e053-2995a90ab85c | 2024-04-15 | Warnings | FAMOTIDINE |
| FAMOTIDINE | FAMOTIDINE | Asclemed USA, Inc. | 69bd5340-298b-46ca-83c7-0b5ef233f9c5 | 2024-04-12 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Hikma Pharmaceuticals USA Inc. | 1fdf16e5-145d-4c19-a318-fc6c10794b50 | 2024-04-09 | Warnings, Adverse reactions | FAMOTIDINE |
| famotidine | FAMOTIDINE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 6daf1ebe-b0a2-4413-bf25-3de6eb64b0c6 | 2024-03-27 | Warnings | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Direct_Rx | 138d9ed1-2f8f-d19d-e063-6394a90a695d | 2024-03-13 | Warnings, Adverse reactions | FAMOTIDINE |
| FAMOTIDINE | FAMOTIDINE | NuCare Pharmaceuticals,Inc. | 13168d9e-0697-e5fb-e063-6294a90a69ba | 2024-03-07 | Warnings, Adverse reactions | FAMOTIDINE |
| Maximum Strength Acid Reducer | FAMOTIDINE | TIME CAP LABORATORIES,INC | fe25e1e2-7158-6fe0-e053-6394a90a3bb1 | 2024-03-06 | Warnings | FAMOTIDINE |
| Famotidine | FAMOTIDINE | DR. REDDY'S LABORATORIES INC | 88ac92eb-5684-46c8-8cd2-3d4aefee26cf | 2024-02-22 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Amneal Pharmaceuticals NY LLC | 443e8ea6-7d51-4db7-8f0b-7a854d45bf23 | 2024-02-13 | Warnings, Adverse reactions | FAMOTIDINE |
| Famotidine | FAMOTIDINE | VKT Pharma Private Limited | 4e5db906-992f-476b-9d97-63a4c582bbdc | 2024-01-25 | Warnings | FAMOTIDINE |
| Famotidine | FAMOTIDINE | Lifestar Pharma LLC | 044a510f-33df-4484-8f07-d821f52b9376 | 2024-01-22 | Warnings, Adverse reactions | FAMOTIDINE |
| Acid Reducer | FAMOTIDINE | Allegiant Health | adc2721d-2ca7-4a47-bae1-be298fa1c155 | 2024-01-16 | Warnings | FAMOTIDINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79323 | SUPPL | 2024-08-07 |
| 79321 | SUPPL | 2024-08-07 |
| 59732 | SUPPL | 2019-08-16 |
| 59713 | SUPPL | 2019-08-15 |
| 1363 | SUPPL | 2007-11-08 |
| 33775 | SUPPL | 2007-11-07 |
| 20252 | SUPPL | 2007-07-09 |
| 33774 | SUPPL | 2004-12-03 |
| 1362 | SUPPL | 2004-12-02 |
| 33773 | SUPPL | 2002-06-06 |
| 1361 | SUPPL | 2002-06-06 |
| 40916 | SUPPL | 1999-03-18 |