Home NDC 66288-1300 CEFAZOLIN
Product NDC 66288-1300
11-digit product format 662881300
Labeler code 66288
Product ID 66288-1300_8476cb2d-2615-4637-ab51-363d639a6022
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEFAZOLIN SODIUM
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Samson Medical Technologies, L.L.C.
Application ANDA065141
Marketing category ANDA
Marketing start 2007-01-01
Substance CEFAZOLIN SODIUM
Active strength 300 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 A065141-001 CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 A065141-002 CEFAZOLIN SODIUM CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29
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 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065141-001 CEFAZOLIN SODIUM EQ 100GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065141-002 CEFAZOLIN SODIUM EQ 300GM BASE/VIAL INJECTABLE / INJECTION RS 2006-11-29 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base CEFAZOLIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFAZOLIN SODIUM 300 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 66288-1300-1 CEFAZOLIN 1 in 1 BAG INJECTION, POWDER, LYOPHILIZED, 1 10
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, LYOPHILIZED, FOR SOLUTION [SAMSON MEDICAL TECHNOLOGIES, L.L.C.] 4 Cefazolin ACTIVE MOIETY IHS69L0Y4T CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAMSON MEDICAL TECHNOLOGIES, L.L.C.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66288-1300 CEFAZOLIN (CEFAZOLIN SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAMSON MEDICAL TECHNOLOGIES, L.L.C.] 10 Current NDC, Legacy NDC, 1 package rows 20250112_cf13db9c-d8a1-489f-9aa0-fc70839d4bbc.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 Marketing start Marketing end Sample Exclude flag Status 66288-1300-1 66288130001 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BAG (66288-1300-1) 2007-01-01 0000-00-00 No No Current