Cefoxitin
- Product NDC
- 63323-341
- 11-digit product format
- 633230341
- Labeler code
- 63323
- Product ID
- 63323-341_0fffe10d-e5bc-4a0c-ae5b-bbf4095990ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefoxitin Sodium
- Dosage form
- POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA065414
- Marketing category
- ANDA
- Marketing start
- 2011-07-06
- Substance
- CEFOXITIN SODIUM
- Active strength
- 1 g/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065414-001 | CEFOXITIN | CEFOXITIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 |
| A065414-002 | CEFOXITIN | CEFOXITIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065414-001 | AP |
| A065414-002 | AP |
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 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065414-001 | CEFOXITIN | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065414-002 | CEFOXITIN | EQ 2GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2009-06-12 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A065414-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A065414-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A065414-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065414-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065414-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065414-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065414-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065414-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065414-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065414-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065414-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065414-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065414-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065414-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065414-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065414-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065414-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065414-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065414-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065414-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065414-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065414-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065414-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065414-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065414-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065414-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065414-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065414-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065414-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065414-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065414-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065414-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065414-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065414-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065414-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065414-002 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065414-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065414-002 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065414-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065414-002 | AP | 1 | bb7c543d1eb4… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cefoxitin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CEFOXITIN SODIUM | 1 g/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| Q68050H03T | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2a9d1e7b-96ee-4e6c-a1e8-47b76b924422 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 674c093f-2e56-4442-b936-d876c9ac5966 | Product name | 1 | 20160111 |
| 33228014-863e-d9a4-2fc1-b5fe1bf2d490 | Product name | 1 | 20140508 |
| cd1ea622-6dd0-ac04-3600-f4b6f14160cc | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-341-01 | Cefoxitin | 1 in 1 VIAL | POWDER, FOR SOLUTION | 1 | 8 | |
| 63323-341-25 | Cefoxitin | 25 in 1 CARTON | POWDER, FOR SOLUTION | 25 | 8 | |
| 63323-341-29 | Cefoxitin | 25 in 1 CARTON | POWDER, FOR SOLUTION | 25 | 6 | |
| 63323-341-41 | Cefoxitin | 1 in 1 VIAL | POWDER, FOR SOLUTION | 1 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-341-01 | EA - Each | 63323-341 | 8fa8de6d-b5fd-487a-bdf2-44af54431ae7 | 1 | 2022-10-06 |
| 63323-341-25 | EA - Each | 63323-341 | 5501a875-b981-41b2-9ffd-a1f6c4ffb8bb | 1 | 2012-07-24 |
| 63323-341-29 | EA - Each | 63323-341 | c48f84d9-810c-4462-a2c5-f81faa8f7d14 | 1 | 2015-04-03 |
| 63323-341-41 | EA - Each | 63323-341 | 5ccf5c56-36b8-4702-9997-ce755dcaa8f3 | 1 | 2025-09-12 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CEFOXITIN SODIUM | ACTIVE INGREDIENT | Q68050H03T | CEFOXITIN (CEFOXITIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| CEFOXITIN | ACTIVE MOIETY | 6OEV9DX57Y | CEFOXITIN (CEFOXITIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| CEFOXITIN SODIUM | ACTIVE INGREDIENT | Q68050H03T | CEFOXITIN (CEFOXITIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| CEFOXITIN | ACTIVE MOIETY | 6OEV9DX57Y | CEFOXITIN (CEFOXITIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-341 | CEFOXITIN (CEFOXITIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC ] | 8 | Current NDC, Legacy NDC, 2 package rows | 20221004_d02170ff-65aa-48b8-a922-94271c46ffa7.zip |
| 63323-341 | CEFOXITIN (CEFOXITIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20230721_2a9d1e7b-96ee-4e6c-a1e8-47b76b924422.zip |
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 | WG Critical Care, LLC | 91ac4c14-8dd8-4efe-a462-d1c488a6184f | 2025-11-12 | Warnings, Adverse reactions | 065414 ANDA065414 |
| Cefoxitin | CEFOXITIN | Sagent Pharmaceuticals | b272ef9c-4d83-4ee2-b9cc-477440822cca | 2024-01-03 | Warnings, Adverse reactions | 065414 ANDA065414 |
| Cefoxitin | CEFOXITIN | WG Critical Care, LLC | 658a0dc6-6da5-44dc-94f2-1211619297f7 | 2023-10-18 | Warnings, Adverse reactions | 065414 ANDA065414 |
| Cefoxitin | CEFOXITIN SODIUM | Fresenius Kabi USA, LLC | 2a9d1e7b-96ee-4e6c-a1e8-47b76b924422 | 2023-07-10 | Warnings, Adverse reactions | 065414 ANDA065414 63323-341 |
| Cefoxitin | CEFOXITIN SODIUM | Fresenius Kabi USA, LLC | d02170ff-65aa-48b8-a922-94271c46ffa7 | 2022-09-23 | Warnings, Adverse reactions | 065414 ANDA065414 63323-341 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63323-341-01 | 63323034101 | 1 in 1 VIAL | Historical | |||||
| 63323-341-25 | 63323034125 | 25 VIAL in 1 CARTON (63323-341-25) / 1 POWDER, FOR SOLUTION in 1 VIAL (63323-341-01) | 25 vial | 2011-07-06 | 0000-00-00 | No | No | Current |
| 63323-341-29 | 63323034129 | 25 VIAL in 1 CARTON (63323-341-29) / 1 POWDER, FOR SOLUTION in 1 VIAL (63323-341-41) | 25 vial | 2011-07-06 | 0000-00-00 | No | No | Current |
| 63323-341-41 | 63323034141 | 1 in 1 VIAL | Historical |