FDA.reportPublic FDA data

Bleomycin

Product NDC
0409-0332
11-digit product format
004090332
Labeler code
0409
Product ID
0409-0332_d9e9c332-1b3f-469c-83b8-41e15183e635
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BLEOMYCIN
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS
Labeler
Hospira, Inc.
Application
ANDA065031
Marketing category
ANDA
Marketing start
2015-04-25
Substance
BLEOMYCIN SULFATE
Active strength
15 [USP'U]/1
Pharmacologic classes
Cytoprotective Agent [EPC]
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 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
A065031-001BLEOMYCIN SULFATEBLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTIONAP2000-03-10
A065031-002BLEOMYCIN SULFATEBLEOMYCIN SULFATEEQ 30 UNITS BASE/VIALINJECTABLE / INJECTIONAP2000-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065031-001AP
A065031-002AP

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 22:54:322026-06A065031-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTIONAP2000-03-10a50c72e98297…
2026-08-01 22:54:322026-06A065031-002BLEOMYCIN SULFATEEQ 30 UNITS BASE/VIALINJECTABLE / INJECTIONAP2000-03-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065031-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A065031-002AP1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BleomycinBLEOMYCINHospira, Inc.905e0984-2ce3-481c-b1a0-0ef0a616479a2022-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065031
application number: ANDA065031
BleomycinBLEOMYCINHospira, Inc.e629ba5a-4e08-4249-9551-af6dbd98a7e42022-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065031
application number: ANDA065031
ndc (product): 0409-0332

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BLEOMYCIN SULFATE15 [USP'U]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7DP3NTV15TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1726673Internal RxNorm lookup
1726676Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e629ba5a-4e08-4249-9551-af6dbd98a7e4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ee93f825-270c-1e25-534e-aae72a8b5314Product name320190619

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-0332-20Bleomycin1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,110
0409-0332-20Bleomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-0332-20EA - Each0409-03321199c0a1-cf12-479b-90ac-5f5372b6573612018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-0332BLEOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]10Current NDC, Legacy NDC, 2 package rows20220827_e629ba5a-4e08-4249-9551-af6dbd98a7e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726673bleomycin 15 UNT InjectionPSNe629ba5a-4e08-4249-9551-af6dbd98a7e410
1726676bleomycin 30 UNT InjectionPSNe629ba5a-4e08-4249-9551-af6dbd98a7e410
1726673bleomycin 15 UNT InjectionSCDe629ba5a-4e08-4249-9551-af6dbd98a7e410
1726676bleomycin 30 UNT InjectionSCDe629ba5a-4e08-4249-9551-af6dbd98a7e410
1726673bleomycin (as bleomycin sulfate) 15 UNT InjectionSYe629ba5a-4e08-4249-9551-af6dbd98a7e410
1726676bleomycin (as bleomycin sulfate) 30 UNT InjectionSYe629ba5a-4e08-4249-9551-af6dbd98a7e410
1726673bleopmycin 15,000 IU InjectionSYe629ba5a-4e08-4249-9551-af6dbd98a7e410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-0332-20004090332201 VIAL, SINGLE-DOSE in 1 CARTON (0409-0332-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2018-04-250000-00-00NoNoCurrent