Home NDC 63323-449 Cefazolin
Product NDC 63323-449
11-digit product format 633230449
Labeler code 63323
Product ID 63323-449_92482dad-bab4-4dd4-e053-2995a90aaf1c
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
Marketing end 0000-00-00
Substance CEFAZOLIN SODIUM
Active strength 20 g/100mL
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63323-449-61 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63323-449-61 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63323-449-61 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63323-449-61 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63323-449-61 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63323-449-61 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 63323-449-61 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 63323-449-61 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 63323-449-61 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 63323-449-61 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 63323-449-61 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63323-449-61 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 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 · 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 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…2021-12-28 21:50 UTC 2021-12 A065306-001 CEFAZOLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE / INJECTION AP 2008-10-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065306-002 CEFAZOLIN SODIUM EQ 20GM BASE/VIAL INJECTABLE / INJECTION RS 2014-08-18 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-449-01 Cefazolin 100 mL in 1 VIAL POWDER, FOR SOLUTION 100 6 63323-449-61 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 63323-449 CEFAZOLIN (CEFAZOLIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC] 6 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 Status 63323-449-01 63323044901 100 mL in 1 VIAL 100 ml Historical 63323-449-61 63323044961 10 in 1 CARTON Historical