Home NDC 63323-238 Cefazolin
Product NDC 63323-238
11-digit product format 633230238
Labeler code 63323
Product ID 63323-238_9684b8e0-7438-41d9-89e1-b217b5568360
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefazolin Sodium
Dosage form POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA065306
Marketing category ANDA
Marketing start 2011-06-14
Substance CEFAZOLIN SODIUM
Active strength 10 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 A065306-001 CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 A065306-002 CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065306-001 AP
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 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 10 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 313920 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 63323-238-01 Cefazolin 1 in 1 VIAL POWDER, FOR SOLUTION 1 6 63323-238-61 Cefazolin 10 in 1 CARTON POWDER, FOR SOLUTION 10 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-238 CEFAZOLIN (CEFAZOLIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20200624_47a8928f-708d-418a-829b-36eded96bac0.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 · 2 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 63323-238-01 63323023801 1 in 1 VIAL Historical 63323-238-61 63323023861 10 VIAL in 1 CARTON (63323-238-61) / 1 POWDER, FOR SOLUTION in 1 VIAL (63323-238-01) 10 vial 2011-06-14 0000-00-00 No No Current