Cefazolin

Product NDC
60505-6143
11-digit product format
605056143
Labeler code
60505
Product ID
60505-6143_0c85a6e9-ce7a-2903-e063-6294a90ad28b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefazolin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA209217
Marketing category
ANDA
Marketing start
2019-03-28
Substance
CEFAZOLIN SODIUM
Active strength
10 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209217-001CEFAZOLIN SODIUMCEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209217-001AP

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2018-10-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2018-10-173f01610625f2…
2019-09-15 20:21 UTC2019-09A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2018-10-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP2018-10-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209217-001CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAPRS2018-10-17e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209217-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209217-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209217-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209217-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209217-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209217-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209217-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209217-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209217-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209217-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209217-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209217-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209217-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209217-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209217-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209217-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209217-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209217-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209217-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209217-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209217-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209217-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A209217-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209217-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209217-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209217-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A209217-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209217-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209217-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209217-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209217-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209217-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209217-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209217-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209217-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209217-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209217-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209217-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209217-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209217-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Cefazolin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFAZOLIN SODIUM10 g/1

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313920Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
81d1783a-2baa-4d65-856a-f5ce38d24804Available 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
60505-6143-0Cefazolin1 in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION16
60505-6143-4Cefazolin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6143-0EA - Each60505-6143fbfa6a37-8664-475f-8a4f-85c3bdc3ab5b12019-05-02
60505-6143-4EA - Each60505-61436f9b16e7-56a4-4f4d-9ad3-541600ea876e12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6143CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [APOTEX CORP.]6Current NDC, Legacy NDC, 2 package rows20231215_81d1783a-2baa-4d65-856a-f5ce38d24804.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
CefazolinCEFAZOLINApotex Corp.0e8d4462-7642-4296-a605-6c1493e91ffd2023-12-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209217
application number: ANDA209217
CefazolinCEFAZOLINApotex Corp.81d1783a-2baa-4d65-856a-f5ce38d248042023-12-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209217
application number: ANDA209217
ndc (product): 60505-6143

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313920ceFAZolin 200 MG/ML InjectionPSN81d1783a-2baa-4d65-856a-f5ce38d248046
313920cefazolin 200 MG/ML Injectable SolutionSCD81d1783a-2baa-4d65-856a-f5ce38d248046
313920cefazolin (as cefazolin sodium) 200 MG/ML Injectable SolutionSY81d1783a-2baa-4d65-856a-f5ce38d248046

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-6143-0605056143001 in 1 VIAL, PHARMACY BULK PACKAGEHistorical
60505-6143-46050561430410 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (60505-6143-4) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (60505-6143-0) 2019-03-280000-00-00NoNoCurrent