Home NDC 0264-3105 Cefazolin Sodium
Product NDC 0264-3105
11-digit product format 002643105
Labeler code 0264
Product ID 0264-3105_fb2f076a-22b3-46e0-86c8-7678e89c9edf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefazolin Sodium
Dosage form SOLUTION
Route INTRAVENOUS
Labeler B. Braun Medical Inc.
Application NDA050779
Marketing category NDA
Marketing start 2012-01-13
Substance CEFAZOLIN SODIUM
Active strength 2 g/50mL
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050779-001 CEFAZOLIN AND DEXTROSE CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2000-07-27 N050779-002 CEFAZOLIN AND DEXTROSE CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2000-07-27 N050779-003 CEFAZOLIN AND DEXTROSE CEFAZOLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE / INJECTION RLD 2012-01-13 N050779-004 CEFAZOLIN AND DEXTROSE CEFAZOLIN SODIUM EQ 3GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2024-08-26
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 4 · 134 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 N050779-001 CEFAZOLIN AND DEXTROSE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2000-07-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050779-002 CEFAZOLIN AND DEXTROSE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2000-07-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050779-003 CEFAZOLIN AND DEXTROSE EQ 2GM BASE/VIAL INJECTABLE / INJECTION RLD 2012-01-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050779-004 CEFAZOLIN AND DEXTROSE EQ 3GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2024-08-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050779-001 CEFAZOLIN AND DEXTROSE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2000-07-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050779-002 CEFAZOLIN AND DEXTROSE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2000-07-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050779-003 CEFAZOLIN AND DEXTROSE EQ 2GM BASE/VIAL INJECTABLE / INJECTION RLD 2012-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050779-004 CEFAZOLIN AND DEXTROSE EQ 3GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2024-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050779-001 CEFAZOLIN AND DEXTROSE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2000-07-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050779-002 CEFAZOLIN AND DEXTROSE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2000-07-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050779-003 CEFAZOLIN AND DEXTROSE EQ 2GM BASE/VIAL INJECTABLE / INJECTION RLD 2012-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050779-004 CEFAZOLIN AND DEXTROSE EQ 3GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2024-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050779-001 CEFAZOLIN AND DEXTROSE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2000-07-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050779-002 CEFAZOLIN AND DEXTROSE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2000-07-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050779-003 CEFAZOLIN AND DEXTROSE EQ 2GM BASE/VIAL INJECTABLE / INJECTION RLD 2012-01-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050779-004 CEFAZOLIN AND DEXTROSE EQ 3GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2024-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050779-001 CEFAZOLIN AND DEXTROSE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2000-07-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050779-002 CEFAZOLIN AND DEXTROSE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2000-07-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050779-003 CEFAZOLIN AND DEXTROSE EQ 2GM BASE/VIAL INJECTABLE / INJECTION RLD 2012-01-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050779-004 CEFAZOLIN AND DEXTROSE EQ 3GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2024-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050779-001 CEFAZOLIN AND DEXTROSE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2000-07-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050779-002 CEFAZOLIN AND DEXTROSE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2000-07-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050779-003 CEFAZOLIN AND DEXTROSE EQ 2GM BASE/VIAL INJECTABLE / INJECTION RLD 2012-01-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050779-004 CEFAZOLIN AND DEXTROSE EQ 3GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2024-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050779-001 CEFAZOLIN AND DEXTROSE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2000-07-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050779-002 CEFAZOLIN AND DEXTROSE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2000-07-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050779-003 CEFAZOLIN AND DEXTROSE EQ 2GM BASE/VIAL INJECTABLE / INJECTION RLD 2012-01-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050779-004 CEFAZOLIN AND DEXTROSE EQ 3GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2024-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050779-001 CEFAZOLIN AND DEXTROSE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2000-07-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050779-002 CEFAZOLIN AND DEXTROSE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2000-07-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050779-003 CEFAZOLIN AND DEXTROSE EQ 2GM BASE/VIAL INJECTABLE / INJECTION RLD 2012-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050779-001 CEFAZOLIN AND DEXTROSE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2000-07-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050779-002 CEFAZOLIN AND DEXTROSE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2000-07-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050779-003 CEFAZOLIN AND DEXTROSE EQ 2GM BASE/VIAL INJECTABLE / INJECTION RLD 2012-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050779-001 CEFAZOLIN AND DEXTROSE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2000-07-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050779-002 CEFAZOLIN AND DEXTROSE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2000-07-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050779-003 CEFAZOLIN AND DEXTROSE EQ 2GM BASE/VIAL INJECTABLE / INJECTION RLD 2012-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050779-001 CEFAZOLIN AND DEXTROSE EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2000-07-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050779-002 CEFAZOLIN AND DEXTROSE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RLD, RS 2000-07-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050779-003 CEFAZOLIN AND DEXTROSE EQ 2GM BASE/VIAL INJECTABLE / INJECTION RLD 2012-01-13 d06236e962d9…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Cefazolin Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFAZOLIN SODIUM 2 g/50mL
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665050 Internal RxNorm lookup 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 0264-3105-11 Cefazolin Sodium 24 in 1 CASE SOLUTION 24 31 0264-3105-11 Cefazolin Sodium 50 mL in 1 CONTAINER SOLUTION 50 31
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0264-3105 CEFAZOLIN SODIUM SOLUTION [B. BRAUN MEDICAL INC.] 31 Current NDC, Legacy NDC, 2 package rows 20250410_17f8f038-c204-4dab-80d7-6f7ac41ddbec.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 Marketing end Sample Exclude flag Status 0264-3105-11 00264310511 24 CONTAINER in 1 CASE (0264-3105-11) / 50 mL in 1 CONTAINER 24 container 2012-01-13 0000-00-00 No No Current