FDA.reportPublic FDA data

Cefuroxime sodium

Product NDC
25021-119
Requested package NDC
25021-119-20
11-digit product format
250210119
Labeler code
25021
Product ID
25021-119_da170a9c-def7-432b-8999-701e7b878fe8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA064125
Marketing category
ANDA
Marketing start
2016-09-01
Substance
CEFUROXIME SODIUM
Active strength
1.5 g/20mL
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 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
A064125-001CEFUROXIME SODIUMCEFUROXIME SODIUMEQ 750MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAB1997-05-30
A064125-002CEFUROXIME SODIUMCEFUROXIME SODIUMEQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP1997-05-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A064125-001AB
A064125-002AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A064125-001CEFUROXIME SODIUMEQ 750MG BASE/VIALINJECTABLE / INTRAMUSCULAR, INTRAVENOUSAB1997-05-30a50c72e98297…
2026-08-01 22:54:322026-06A064125-002CEFUROXIME SODIUMEQ 1.5GM BASE/VIALINJECTABLE / INJECTIONAP1997-05-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A064125-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A064125-002AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cefuroxime sodiumCEFUROXIME SODIUMSagent Pharmaceuticals0a145288-733a-4966-b7ae-dc96eb103d8c2025-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064125
application number: ANDA064125
ndc (package): 25021-119-20
ndc (product): 25021-119
ndc11 (package): 25021011920

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFUROXIME SODIUM1.5 g/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R8A7M9MY61Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1665444Internal RxNorm lookup
1665449Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a145288-733a-4966-b7ae-dc96eb103d8cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba66f2a7-7ba5-e81a-8863-a38bd5c2e969Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-119-20Cefuroxime sodium25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2510
25021-119-20Cefuroxime sodium20 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION2010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-119-20EA - Each25021-1196dc771b8-f735-44ac-9241-e2d88a5f547112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cefuroxime sodiumACTIVE INGREDIENTR8A7M9MY61CEFUROXIME SODIUM INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]3
cefuroximeACTIVE MOIETYO1R9FJ93EDCEFUROXIME SODIUM INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-119CEFUROXIME SODIUM INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]9Current NDC, Legacy NDC, 2 package rows20250304_0a145288-733a-4966-b7ae-dc96eb103d8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665444cefuroxime 1.5 GM InjectionPSN0a145288-733a-4966-b7ae-dc96eb103d8c10
1665449cefuroxime 750 MG InjectionPSN0a145288-733a-4966-b7ae-dc96eb103d8c10
1665444cefuroxime 1500 MG InjectionSCD0a145288-733a-4966-b7ae-dc96eb103d8c10
1665449cefuroxime 750 MG InjectionSCD0a145288-733a-4966-b7ae-dc96eb103d8c10
1665444cefuroxime 1.5 GM InjectionSY0a145288-733a-4966-b7ae-dc96eb103d8c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-119-202502101192025 VIAL in 1 CARTON (25021-119-20) / 20 mL in 1 VIAL25 vial2016-09-010000-00-00NoNoCurrent