CEFAZOLIN
- Product NDC
- 52584-924
- 11-digit product format
- 525840924
- Labeler code
- 52584
- Product ID
- 52584-924_c8f69e4a-5deb-4349-89d7-85a10a5c0ba0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cefazolin
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- General Injectables and Vaccines, Inc.
- Application
- ANDA065047
- Marketing category
- ANDA
- Marketing start
- 2020-11-19
- Marketing end
- 2025-01-31
- Substance
- CEFAZOLIN SODIUM
- Active strength
- 330 mg/mL
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 52584-924 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 52584-924 | 52584-924-90 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52584-924-90 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52584-924-90 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52584-924-90 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52584-924-90 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52584-924-90 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52584-924-90 | cdf11ea48f46… | ba0047e9e063… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065047-001 | CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 |
| A065047-002 | CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065047-001 | AP |
| A065047-002 | 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 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | 2001-09-18 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | 2001-09-18 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065047-001 | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065047-002 | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | AP | RS | 2001-09-18 | 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 | A065047-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A065047-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A065047-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065047-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065047-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065047-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065047-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065047-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065047-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065047-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065047-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065047-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065047-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065047-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065047-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065047-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065047-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065047-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065047-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065047-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065047-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065047-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065047-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065047-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065047-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065047-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065047-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065047-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065047-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065047-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065047-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065047-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065047-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065047-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065047-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065047-002 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065047-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065047-002 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065047-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065047-002 | AP | 1 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| Cefazolin | CEFAZOLIN | Hikma Pharmaceuticals USA Inc. | 26de1ce9-06a9-486f-b27d-2ac635f018d1 | 2026-05-14 | Warnings, Adverse reactions | 065047 ANDA065047 |
| Cefazolin | CEFAZOLIN | Civica, Inc. | 9ea55207-6d86-401e-b9b9-73c9534a233f | 2026-05-14 | Warnings, Adverse reactions | 065047 ANDA065047 |
| Cefazolin | CEFAZOLIN | Hikma Pharmaceuticals USA Inc. | 1dc9de56-e259-4546-a1db-23119a8a088e | 2026-05-14 | Warnings, Adverse reactions | 065047 ANDA065047 |
| CEFAZOLIN | CEFAZOLIN | Henry Schein, Inc. | 197d5702-2c20-480e-8246-4d0d21f871be | 2025-10-27 | Warnings | 065047 ANDA065047 |
| CEFAZOLIN | CEFAZOLIN | Henry Schein Inc. | 922fb1a1-ad4c-4a12-8d5d-00fe13af18e8 | 2025-10-27 | Warnings, Adverse reactions | 065047 ANDA065047 |
| Cefazolin | CEFAZOLIN | A-S Medication Solutions | 8a772acc-726d-40e6-88ee-b6075cbf9b28 | 2023-06-23 | Warnings, Adverse reactions | 065047 ANDA065047 |
| Cefazolin | CEFAZOLIN | Medical Purchasing Solutions, LLC | 6673be13-4c74-70b9-e053-2a91aa0a211d | 2023-06-01 | Warnings, Adverse reactions | 065047 ANDA065047 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52584-924-90 | 52584092490 | 1 VIAL in 1 BAG (52584-924-90) > 3 mL in 1 VIAL | 1 vial | 2020-11-19 | 0000-00-00 | No | No | Current |