Cefazolin

Product NDC
67184-0560
11-digit product format
671840560
Labeler code
67184
Product ID
67184-0560_95b71327-9f42-42f2-8526-dc8bb58580c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefazolin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Qilu Pharmaceutical Co., Ltd.
Application
ANDA203661
Marketing category
ANDA
Marketing start
2022-03-18
Marketing end
0000-00-00
Substance
CEFAZOLIN SODIUM
Active strength
2 g/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct67184-0560IInactivated by FDA2026-08-03
excluded packagepackage67184-056067184-0560-2IInactivated by FDA2026-08-03

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 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67184-0560-2IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67184-0560-2IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67184-0560-2IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67184-0560-2IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67184-0560-2IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67184-0560-2IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67184-0560-2UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67184-0560-2UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67184-0560-2UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203661-001CEFAZOLIN SODIUMCEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-12-28
A203661-002CEFAZOLIN SODIUMCEFAZOLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2022-03-11
A203661-003CEFAZOLIN SODIUMCEFAZOLIN SODIUMEQ 3GM BASE/VIALINJECTABLE / INJECTION2024-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203661-001AP

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203661-001CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203661-002CEFAZOLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2022-03-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203661-003CEFAZOLIN SODIUMEQ 3GM BASE/VIALINJECTABLE / INJECTION2024-01-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203661-001CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203661-002CEFAZOLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2022-03-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203661-003CEFAZOLIN SODIUMEQ 3GM BASE/VIALINJECTABLE / INJECTION2024-01-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A203661-001CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203661-002CEFAZOLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2022-03-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203661-003CEFAZOLIN SODIUMEQ 3GM BASE/VIALINJECTABLE / INJECTION2024-01-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203661-001CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203661-002CEFAZOLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2022-03-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203661-003CEFAZOLIN SODIUMEQ 3GM BASE/VIALINJECTABLE / INJECTION2024-01-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203661-001CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203661-002CEFAZOLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2022-03-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203661-003CEFAZOLIN SODIUMEQ 3GM BASE/VIALINJECTABLE / INJECTION2024-01-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203661-001CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203661-002CEFAZOLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2022-03-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203661-003CEFAZOLIN SODIUMEQ 3GM BASE/VIALINJECTABLE / INJECTION2024-01-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203661-001CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203661-002CEFAZOLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2022-03-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203661-003CEFAZOLIN SODIUMEQ 3GM BASE/VIALINJECTABLE / INJECTION2024-01-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203661-001CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203661-002CEFAZOLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2022-03-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203661-003CEFAZOLIN SODIUMEQ 3GM BASE/VIALINJECTABLE / INJECTION2024-01-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203661-001CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203661-002CEFAZOLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2022-03-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203661-003CEFAZOLIN SODIUMEQ 3GM BASE/VIALINJECTABLE / INJECTION2024-01-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203661-001CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A203661-002CEFAZOLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2022-03-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A203661-003CEFAZOLIN SODIUMEQ 3GM BASE/VIALINJECTABLE / INJECTION2024-01-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203661-001CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203661-002CEFAZOLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2022-03-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203661-003CEFAZOLIN SODIUMEQ 3GM BASE/VIALINJECTABLE / INJECTION2024-01-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203661-001CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203661-002CEFAZOLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2022-03-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203661-003CEFAZOLIN SODIUMEQ 3GM BASE/VIALINJECTABLE / INJECTION2024-01-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203661-001CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-12-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203661-002CEFAZOLIN SODIUMEQ 2GM BASE/VIALINJECTABLE / INJECTION2022-03-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203661-003CEFAZOLIN SODIUMEQ 3GM BASE/VIALINJECTABLE / INJECTION2024-01-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203661-001CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2015-12-288072bd15b7f6…

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 UTC2026-02A203661-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203661-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203661-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203661-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203661-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203661-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203661-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203661-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203661-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203661-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203661-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203661-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203661-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203661-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203661-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203661-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203661-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203661-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203661-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203661-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203661-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A203661-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203661-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203661-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203661-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A203661-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203661-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203661-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203661-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203661-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203661-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203661-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203661-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203661-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203661-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203661-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203661-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203661-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203661-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203661-001AP1cb3db0bc1861…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67184-0560-22025-01-30C16284748780-12cef2736-8e0e-d83d-e063-dadaa90ab31fCefazolin for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67184-0560-1Cefazolin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION17
67184-0560-2Cefazolin25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67184-0560CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [QILU PHARMACEUTICAL CO., LTD.]7Legacy NDC, 2 package rows20231219_e8bd9e95-8af5-416b-b58c-e1dbe3d052ac.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CEFAZOLINCEFAZOLINHenry Schein, Inc.5a8c4bb2-a75e-4d7d-91fb-9a95f04fc94b2025-10-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203661
application number: ANDA203661
CefazolinCEFAZOLINProPharma Distribution3d5cc73c-8a41-b285-e063-6294a90a609f2025-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203661
application number: ANDA203661
CefazolinCEFAZOLINApotex Corp.0422fe47-c372-494f-bac2-612f550b44a42025-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203661
application number: ANDA203661
Cefazolin SodiumCEFAZOLIN SODIUMDirect_rx22dfc2e4-07a7-8d13-e063-6394a90a3e9f2024-09-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203661
application number: ANDA203661
CefazolinCEFAZOLINQilu Pharmaceutical Co., Ltd.e8bd9e95-8af5-416b-b58c-e1dbe3d052ac2023-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203661
application number: ANDA203661
ndc (product): 67184-0560
CefazolinCEFAZOLINApotex Corp.37a626aa-96dc-4c4d-bfbc-be4f328f918b2023-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203661
application number: ANDA203661
CefazolinCEFAZOLINMedical Purchasing Solutions, LLC79787707-c84f-f229-e053-2a91aa0a1f162023-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203661
application number: ANDA203661
CefazolinCEFAZOLINProficient Rx LPd24529e3-e2b4-46d6-81ba-b7da745017922022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203661
application number: ANDA203661

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665050ceFAZolin 1 GM InjectionPSNe8bd9e95-8af5-416b-b58c-e1dbe3d052ac7
1665060ceFAZolin 2 GM InjectionPSNe8bd9e95-8af5-416b-b58c-e1dbe3d052ac7
1665050cefazolin 1000 MG InjectionSCDe8bd9e95-8af5-416b-b58c-e1dbe3d052ac7
1665060cefazolin 2000 MG InjectionSCDe8bd9e95-8af5-416b-b58c-e1dbe3d052ac7
1665060cefazolin (as cefazolin sodium) 2 GM InjectionSYe8bd9e95-8af5-416b-b58c-e1dbe3d052ac7
1665050cefazolin 1 GM (as cefazolin sodium) InjectionSYe8bd9e95-8af5-416b-b58c-e1dbe3d052ac7
1665050cefazolin 1 GM InjectionSYe8bd9e95-8af5-416b-b58c-e1dbe3d052ac7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67184-0560-1671840560011 in 1 VIALHistorical
67184-0560-26718405600225 VIAL in 1 CARTON (67184-0560-2) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (67184-0560-1) 25 vial2022-03-180000-00-00NoNoCurrent