Home NDC 43858-100 Cefazolin
Product NDC 43858-100
11-digit product format 438580100
Labeler code 43858
Product ID 43858-100_65958fd2-01d1-4ca2-8435-1f4f7a639d53
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefazolin
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Sandoz GmbH
Application ANDA065345
Marketing category ANDA
Marketing start 2007-05-09
Marketing end 0000-00-00
Substance CEFAZOLIN SODIUM
Active strength 1 g/1
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065345-001 CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2007-05-09
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.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table 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 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2007-05-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2007-05-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2007-05-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065345-001 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2007-05-09 e64feba35796…
Observed Orange Book normalized TE history# 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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43858-100-85 43858010085 25 VIAL in 1 CARTON (43858-100-85) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 25 vial 2007-08-07 0000-00-00 No No Current