Cefazolin

Product NDC
0781-3452
11-digit product format
007813452
Labeler code
0781
Product ID
0781-3452_c888c95b-df82-4261-854e-f74f9b2179e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefazolin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS; PARENTERAL
Labeler
Sandoz Inc
Application
ANDA062831
Marketing category
ANDA
Marketing start
1988-12-09
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062831-001CEFAZOLIN SODIUMCEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1988-12-09
A062831-002CEFAZOLIN SODIUMCEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP1988-12-09
A062831-003CEFAZOLIN SODIUMCEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP1992-09-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A062831-001AP
A062831-002AP
A062831-003AP

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A062831-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1988-12-09caaa826d4ba7…
2026-08-18 06:07:402026-07A062831-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP1988-12-09caaa826d4ba7…
2026-08-18 06:07:402026-07A062831-003CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP1992-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062831-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1988-12-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062831-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP1988-12-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062831-003CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP1992-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062831-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1988-12-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062831-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP1988-12-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062831-003CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP1992-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A062831-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1988-12-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062831-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP1988-12-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062831-003CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP1992-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062831-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1988-12-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062831-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP1988-12-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062831-003CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP1992-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062831-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1988-12-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062831-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP1988-12-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062831-003CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP1992-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062831-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1988-12-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062831-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP1988-12-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062831-003CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP1992-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062831-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1988-12-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062831-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP1988-12-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062831-003CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP1992-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062831-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1988-12-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062831-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP1988-12-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062831-003CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP1992-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062831-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1988-12-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062831-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP1988-12-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062831-003CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP1992-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062831-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1988-12-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A062831-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP1988-12-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A062831-003CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP1992-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062831-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1988-12-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062831-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP1988-12-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062831-003CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP1992-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062831-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1988-12-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062831-002CEFAZOLIN SODIUMEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP1988-12-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062831-003CEFAZOLIN SODIUMEQ 10GM BASE/VIALINJECTABLE / INJECTIONAP1992-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062831-001CEFAZOLIN SODIUMEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP1988-12-091e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A062831-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A062831-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A062831-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A062831-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062831-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062831-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062831-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062831-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062831-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062831-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062831-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062831-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062831-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062831-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062831-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062831-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062831-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062831-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062831-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062831-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062831-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062831-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062831-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062831-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062831-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062831-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062831-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062831-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062831-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062831-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062831-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062831-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062831-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062831-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062831-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062831-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062831-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062831-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062831-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062831-001AP11e350fbaab3a…

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
e58f87fb-a47d-4081-a454-e4e916e2f629Available 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
0781-3452-46Cefazolin1 in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION118
0781-3452-95Cefazolin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3452-46EA - Each0781-34525e43cd9a-858d-432f-974a-1dcee86d7e8f12012-07-24
0781-3452-95EA - Each0781-3452f5bed9a6-1b5d-4805-8156-2af516a3029f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFAZOLIN SODIUMACTIVE INGREDIENTP380M0454ZCEFAZOLIN INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]12
CEFAZOLINACTIVE MOIETYIHS69L0Y4TCEFAZOLIN INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3452CEFAZOLIN INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]18Current NDC, Legacy NDC, 2 package rows20241215_e58f87fb-a47d-4081-a454-e4e916e2f629.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
CefazolinCEFAZOLINSandoz Inc18e7366a-1b3e-4010-8f4a-dd559d4f21462025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062831
application number: ANDA062831
CefazolinCEFAZOLINSandoz Ince58f87fb-a47d-4081-a454-e4e916e2f6292020-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062831
application number: ANDA062831
ndc (product): 0781-3452

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313920ceFAZolin 200 MG/ML InjectionPSNe58f87fb-a47d-4081-a454-e4e916e2f62918
313920cefazolin 200 MG/ML Injectable SolutionSCDe58f87fb-a47d-4081-a454-e4e916e2f62918
313920cefazolin (as cefazolin sodium) 200 MG/ML Injectable SolutionSYe58f87fb-a47d-4081-a454-e4e916e2f62918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-3452-46007813452461 in 1 VIAL, PHARMACY BULK PACKAGEHistorical
0781-3452-950078134529510 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0781-3452-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3452-46) 1988-12-090000-00-00NoNoCurrent