Home NDC 44567-120 Cefazolin
Product NDC 44567-120
11-digit product format 445670120
Labeler code 44567
Product ID 44567-120_48aafe01-7d9c-42a7-bed6-6bff79c63a42
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefazolin
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler WG Critical Care, LLC
Application ANDA065303
Marketing category ANDA
Marketing start 2019-04-23
Substance CEFAZOLIN SODIUM
Active strength 1 g/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 A065303-001 CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 A065303-002 CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 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 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cefazolin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFAZOLIN SODIUM 1 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665050 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 44567-120-25 Cefazolin 25 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 25 6 44567-120-25 Cefazolin 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44567-120 CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20250117_00dd6da7-50a8-44c9-b2dc-7948973df392.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44567-120-25 44567012025 25 VIAL in 1 CARTON (44567-120-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 25 vial 2019-04-23 0000-00-00 No No Current