Cefazolin

Product NDC
0143-9923
11-digit product format
001439923
Labeler code
0143
Product ID
0143-9923_6cdaf80f-9ba2-4b0f-903d-61e0811ffaae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefazolin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065047
Marketing category
ANDA
Marketing start
2001-09-18
Substance
CEFAZOLIN SODIUM
Active strength
225 mg/mL
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065047-001CEFAZOLIN SODIUMCEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18
A065047-002CEFAZOLIN SODIUMCEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A065047-001AP
A065047-002AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18caaa826d4ba7…
2026-08-18 06:07:402026-07A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2001-09-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2001-09-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065047-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065047-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS2001-09-18bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A065047-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A065047-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065047-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065047-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065047-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065047-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065047-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065047-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065047-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065047-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065047-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065047-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065047-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065047-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065047-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065047-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065047-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065047-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065047-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065047-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065047-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065047-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065047-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065047-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065047-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065047-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065047-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065047-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065047-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065047-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065047-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065047-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065047-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065047-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065047-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065047-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065047-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065047-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065047-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065047-002AP1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Cefazolin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFAZOLIN SODIUM225 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P380M0454ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1665050Internal RxNorm lookup
1665052Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1dc9de56-e259-4546-a1db-23119a8a088eAvailable on FDA.report

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
0143-9923-90Cefazolin2.2 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION2.213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9923-90EA - Each0143-9923adf6f918-67a5-463c-89ee-cec8f9f1c47012012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9923CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]12Current NDC, Legacy NDC, 1 package rows20240605_1dc9de56-e259-4546-a1db-23119a8a088e.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefazolinCEFAZOLINHikma Pharmaceuticals USA Inc.26de1ce9-06a9-486f-b27d-2ac635f018d12026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065047
application number: ANDA065047
CefazolinCEFAZOLINCivica, Inc.9ea55207-6d86-401e-b9b9-73c9534a233f2026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065047
application number: ANDA065047
CefazolinCEFAZOLINHikma Pharmaceuticals USA Inc.1dc9de56-e259-4546-a1db-23119a8a088e2026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065047
application number: ANDA065047
ndc (product): 0143-9923
CEFAZOLINCEFAZOLINHenry Schein, Inc.197d5702-2c20-480e-8246-4d0d21f871be2025-10-27WarningsExact identifier
application applno (ANDA): 065047
application number: ANDA065047
CEFAZOLINCEFAZOLINHenry Schein Inc.922fb1a1-ad4c-4a12-8d5d-00fe13af18e82025-10-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065047
application number: ANDA065047
CefazolinCEFAZOLINA-S Medication Solutions8a772acc-726d-40e6-88ee-b6075cbf9b282023-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065047
application number: ANDA065047
CefazolinCEFAZOLINMedical Purchasing Solutions, LLC6673be13-4c74-70b9-e053-2a91aa0a211d2023-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065047
application number: ANDA065047

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665050ceFAZolin 1 GM InjectionPSN1dc9de56-e259-4546-a1db-23119a8a088e13
1665052ceFAZolin 500 MG InjectionPSN1dc9de56-e259-4546-a1db-23119a8a088e13
1665050cefazolin 1000 MG InjectionSCD1dc9de56-e259-4546-a1db-23119a8a088e13
1665052cefazolin 500 MG InjectionSCD1dc9de56-e259-4546-a1db-23119a8a088e13
1665052cefazolin (as cefazolin sodium) 500 MG InjectionSY1dc9de56-e259-4546-a1db-23119a8a088e13
1665050cefazolin 1 GM (as cefazolin sodium) InjectionSY1dc9de56-e259-4546-a1db-23119a8a088e13
1665050cefazolin 1 GM InjectionSY1dc9de56-e259-4546-a1db-23119a8a088e13
1665052ceFAZolin 500 MG InjectionPSN922fb1a1-ad4c-4a12-8d5d-00fe13af18e86
1665052cefazolin 500 MG InjectionSCD922fb1a1-ad4c-4a12-8d5d-00fe13af18e86
1665052cefazolin (as cefazolin sodium) 500 MG InjectionSY922fb1a1-ad4c-4a12-8d5d-00fe13af18e86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9923-90001439923902.2 mL in 1 VIAL (0143-9923-90) 2.2 ml2001-09-180000-00-00NoNoCurrent