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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63323-449DDiscontinued by firm2026-08-03
excluded packagepackage63323-44963323-449-61DDiscontinued by firm2026-08-03

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63323-449-61d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63323-449-61f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63323-449-612ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63323-449-61a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63323-449-61cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63323-449-61cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63323-449-61302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63323-449-61ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63323-449-610efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63323-449-61ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63323-449-61367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63323-449-61557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065306-001CEFAZOLIN SODIUMCEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-22
A065306-002CEFAZOLIN SODIUMCEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A065306-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065306-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2008-10-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A065306-002CEFAZOLIN SODIUMEQ 20GM BASE/VIALINJECTABLE / INJECTIONRS2014-08-18782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065306-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065306-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065306-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065306-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065306-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065306-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065306-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065306-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065306-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065306-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065306-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065306-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065306-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065306-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065306-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065306-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065306-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065306-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065306-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065306-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065306-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A065306-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065306-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065306-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065306-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A065306-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065306-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065306-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065306-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065306-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065306-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065306-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065306-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065306-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065306-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065306-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065306-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065306-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065306-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065306-001AP1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4c53c44d-0495-40c1-9f02-9d772dc7a5c7Product name120250318
53d47d5d-6076-4275-8f76-06d261cff1e8Product name120231011
9afe2d9a-f7f6-416b-9ddf-b780a2810bd5Product name120230912
6e62eeca-6666-f31f-9873-48ea9ede8354Product name220190214
afa25392-d76e-4453-8841-fde3a34824f1Product name220160309
53cae805-773b-4bc5-a836-3e22e250892eProduct name120150922
05d4c919-c877-4ec4-cb08-9fcbbbfd8c70Product name120140508
75ba2549-0297-c880-16c8-4fa502c95a9dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-449-01Cefazolin100 mL in 1 VIALPOWDER, FOR SOLUTION1006
63323-449-61Cefazolin10 in 1 CARTONPOWDER, FOR SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-449-61EA - Each63323-44957124894-d204-4bbe-af16-eef449b7f60f12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFAZOLIN SODIUMACTIVE INGREDIENTP380M0454ZCEFAZOLIN (CEFAZOLIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]3
CEFAZOLINACTIVE MOIETYIHS69L0Y4TCEFAZOLIN (CEFAZOLIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-449CEFAZOLIN (CEFAZOLIN SODIUM) POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]6Legacy NDC, 2 package rows20200624_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefazolinCEFAZOLINWG Critical Care, LLC1999084a-124c-45f9-801f-416a1b942c962026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065306
application number: ANDA065306
CefazolinCEFAZOLIN SODIUMFresenius Kabi USA, LLC47a8928f-708d-418a-829b-36eded96bac02020-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065306
application number: ANDA065306
ndc (product): 63323-449

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313920ceFAZolin 200 MG/ML InjectionPSN47a8928f-708d-418a-829b-36eded96bac06
313920cefazolin 200 MG/ML Injectable SolutionSCD47a8928f-708d-418a-829b-36eded96bac06
313920cefazolin (as cefazolin sodium) 200 MG/ML Injectable SolutionSY47a8928f-708d-418a-829b-36eded96bac06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63323-449-0163323044901100 mL in 1 VIAL100 mlHistorical
63323-449-616332304496110 in 1 CARTONHistorical