Home NDC 0781-3451 Cefazolin
Product NDC 0781-3451
11-digit product format 007813451
Labeler code 0781
Product ID 0781-3451_05cd44b2-275f-44f5-b4f8-22393df834a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefazolin
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; PARENTERAL
Labeler Sandoz Inc
Application ANDA062831
Marketing category ANDA
Marketing start 1988-12-09
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A062831-001 CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 A062831-002 CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 A062831-003 CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 1992-09-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 A062831-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062831-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A062831-003 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 1992-09-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062831-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062831-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062831-003 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 1992-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062831-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062831-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062831-003 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 1992-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062831-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062831-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062831-003 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 1992-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062831-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062831-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062831-003 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 1992-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062831-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062831-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062831-003 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 1992-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062831-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062831-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062831-003 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 1992-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062831-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062831-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062831-003 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 1992-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062831-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062831-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062831-003 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 1992-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062831-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062831-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062831-003 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 1992-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062831-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062831-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062831-003 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 1992-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062831-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062831-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062831-003 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 1992-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062831-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062831-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062831-003 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 1992-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062831-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 1988-12-09 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 · 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 0781-3451-70 Cefazolin 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 19 0781-3451-95 Cefazolin 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 19 0781-3451-96 Cefazolin 25 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 25 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-3451 CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [SANDOZ INC] 18 Current NDC, Legacy NDC, 3 package rows 20241218_18e7366a-1b3e-4010-8f4a-dd559d4f2146.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 0781-3451-70 00781345170 1 in 1 VIAL Historical 0781-3451-95 00781345195 10 VIAL in 1 CARTON (0781-3451-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3451-70) 10 vial 2026-01-05 No No Current 0781-3451-96 00781345196 25 VIAL in 1 CARTON (0781-3451-96) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3451-70) 25 vial 1988-12-09 0000-00-00 No No Current