Home NDC 25021-100-66 cefazolin
Product NDC 25021-100
Requested package NDC 25021-100-66
11-digit product format 250210100
Labeler code 25021
Product ID 25021-100_6dfa594e-90e8-4085-af30-6d3660a6bebf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cefazolin sodium
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA065303
Marketing category ANDA
Marketing start 2009-02-01
Marketing end 0000-00-00
Substance CEFAZOLIN SODIUM
Active strength 500 mg/2.2mL
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 82 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 2026-02-19 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…2021-12-28 21:50 UTC 2021-12 A065303-001 CEFAZOLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065303-002 CEFAZOLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded cefazolin sodium ACTIVE INGREDIENT P380M0454Z CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 7 cefazolin ACTIVE MOIETY IHS69L0Y4T CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 7 Cefazolin Sodium ACTIVE INGREDIENT P380M0454Z CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 2 cefazolin ACTIVE MOIETY IHS69L0Y4T CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-100 CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS] 14 Legacy NDC 20240302_e8f40f72-3cf0-43dc-a797-fb98dd8af228.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 25021-100-66 25021010066 25 VIAL in 1 CARTON (25021-100-66) > 2.2 mL in 1 VIAL 25 vial 2015-07-01 0000-00-00 No No Current