Home NDC 63323-236 CEFAZOLIN
Product NDC 63323-236
11-digit product format 633230236
Labeler code 63323
Product ID 63323-236_321ffc80-ee94-4a86-8c33-e966438d9fbb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEFAZOLIN SODIUM
Dosage form POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA065303
Marketing category ANDA
Marketing start 2011-07-15
Substance CEFAZOLIN SODIUM
Active strength 500 mg/2.2mL
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 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFAZOLIN SODIUM 500 mg/2.2mL
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 1665050 Internal RxNorm lookup 1665052 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 63323-236-01 CEFAZOLIN 2.2 mL in 1 VIAL POWDER, FOR SOLUTION 2.2 8 63323-236-10 CEFAZOLIN 25 in 1 CARTON POWDER, FOR SOLUTION 25 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-236 CEFAZOLIN (CEFAZOLIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] 8 Current NDC, Legacy NDC, 2 package rows 20231019_c47c8d14-1eef-40f9-9d11-f0c300b1d4be.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 63323-236-01 63323023601 2.2 mL in 1 VIAL 2.2 ml Historical 63323-236-10 63323023610 25 VIAL in 1 CARTON (63323-236-10) / 2.2 mL in 1 VIAL (63323-236-01) 25 vial 2011-07-15 0000-00-00 No No Current