Home NDC 0143-9139 Cefazolin
Product NDC 0143-9139
11-digit product format 001439139
Labeler code 0143
Product ID 0143-9139_e32063de-96fe-4fb4-9176-5a9d6dc4a722
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefazolin
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA216109
Marketing category NDA
Marketing start 2023-03-01
Substance CEFAZOLIN SODIUM
Active strength 2 g/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216109-001 CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 N216109-002 CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07
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 · 52 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 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216109-001 CEFAZOLIN SODIUM EQ 2GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216109-002 CEFAZOLIN SODIUM EQ 3GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-10-07 9b2671bbb829…
Additional Listing Data#
Finished product Yes
Brand name base Cefazolin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFAZOLIN SODIUM 2 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P380M0454Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665060 Internal RxNorm lookup 2630753 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0143-9139-25 Cefazolin 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 13 0143-9139-25 Cefazolin 25 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 25 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9139 CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 12 Current NDC, 2 package rows 20240417_6c7761d3-c154-4802-9876-627cd42913f0.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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0143-9139-25 00143913925 25 VIAL in 1 CARTON (0143-9139-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 25 vial 2023-03-01 No No Current