Application 050581
- Type
- NDA
- Sponsor
- MERCK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | CEFOXITIN SODIUM | INJECTABLE;INJECTION | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | CEFOXITIN SODIUM | INJECTABLE;INJECTION | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CEFOXITIN SODIUM | INJECTABLE;INJECTION | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CEFOXITIN SODIUM | INJECTABLE;INJECTION | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N050581-001 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | CEFOXITIN SODIUM | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | |
| N050581-002 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | CEFOXITIN SODIUM | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | |
| N050581-003 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CEFOXITIN SODIUM | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | |
| N050581-004 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CEFOXITIN SODIUM | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N050581-001 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050581-002 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050581-003 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050581-004 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050581-001 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050581-002 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050581-003 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050581-004 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050581-001 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050581-002 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050581-003 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050581-004 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050581-001 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050581-002 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050581-003 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050581-004 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050581-001 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050581-002 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050581-003 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050581-004 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050581-001 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050581-002 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050581-003 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050581-004 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050581-001 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050581-002 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050581-003 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050581-004 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050581-001 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050581-002 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050581-003 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050581-004 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050581-001 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050581-002 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050581-003 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050581-004 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050581-001 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050581-002 | MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050581-003 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050581-004 | MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-09-20 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| Cefoxitin | CEFOXITIN SODIUM | Fresenius Kabi USA, LLC | 2a9d1e7b-96ee-4e6c-a1e8-47b76b924422 | 2023-07-10 | Warnings, Adverse reactions | CEFOXITIN SODIUM |
| Cefoxitin | CEFOXITIN SODIUM | Fresenius Kabi USA, LLC | d02170ff-65aa-48b8-a922-94271c46ffa7 | 2022-09-23 | Warnings, Adverse reactions | CEFOXITIN SODIUM |
| Cefoxitin and Dextrose | CEFOXITIN SODIUM | B. Braun Medical Inc. | 6c7e9485-1ede-411c-8c46-911439332864 | 2019-07-29 | Warnings, Adverse reactions | CEFOXITIN SODIUM |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 42650 | SUPPL | 2004-08-10 |