Application 063002
- Type
- ANDA
- Sponsor
- BAXTER HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ANCEF IN PLASTIC CONTAINER | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 10MG BASE/ML | No | No |
| 002 | ANCEF IN PLASTIC CONTAINER | CEFAZOLIN SODIUM | INJECTABLE;INJECTION | EQ 20MG BASE/ML | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A063002-001 | ANCEF IN PLASTIC CONTAINER | CEFAZOLIN SODIUM | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | ||
| A063002-002 | ANCEF IN PLASTIC CONTAINER | CEFAZOLIN SODIUM | EQ 20MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 |
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 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | RS | 1991-03-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | RS | 1991-03-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | RS | 1991-03-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A063002-001 | ANCEF IN PLASTIC CONTAINER | EQ 10MG BASE/ML | INJECTABLE / INJECTION | 1991-03-28 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A063002-002 | ANCEF IN PLASTIC CONTAINER | EQ 20MG BASE/ML | INJECTABLE / INJECTION | RS | 1991-03-28 | 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 |
|---|---|---|---|---|---|---|
| Cefazolin Sodium | CEFAZOLIN SODIUM | B. Braun Medical Inc. | 17f8f038-c204-4dab-80d7-6f7ac41ddbec | 2025-03-10 | Warnings, Adverse reactions | CEFAZOLIN SODIUM |
| CEFAZOLIN | CEFAZOLIN SODIUM | Samson Medical Technologies, L.L.C. | cf13db9c-d8a1-489f-9aa0-fc70839d4bbc | 2025-01-08 | Warnings, Adverse reactions | CEFAZOLIN SODIUM |
| Cefazolin Sodium | CEFAZOLIN SODIUM | Direct_rx | 22dfc2e4-07a7-8d13-e063-6394a90a3e9f | 2024-09-24 | Warnings, Adverse reactions | CEFAZOLIN SODIUM |
| CEFAZOLIN | CEFAZOLIN SODIUM | Fresenius Kabi USA, LLC | c47c8d14-1eef-40f9-9d11-f0c300b1d4be | 2023-09-27 | Warnings, Adverse reactions | CEFAZOLIN SODIUM |
| Cefazolin | CEFAZOLIN SODIUM | Fresenius Kabi USA, LLC | 47a8928f-708d-418a-829b-36eded96bac0 | 2020-06-17 | Boxed warning, Warnings, Adverse reactions | CEFAZOLIN SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0338-3503 | Cefazolin | Cefazolin Sodium | Baxter Healthcare Corporation | ANDA | Current |
| 0338-3503 | Cefazolin | Cefazolin Sodium | Baxter Healthcare Corporation | ANDA | Current |
| 0338-3503 | Cefazolin | Cefazolin Sodium | Baxter Healthcare Corporation | ANDA | Current |
| 0338-3503 | Cefazolin | Cefazolin Sodium | Baxter Healthcare Corporation | ANDA | Current |
| 0338-3503 | Cefazolin | Cefazolin Sodium | Baxter Healthcare Corporation | ANDA | Current |