FDA.reportPublic FDA data

Bleomycin

Product NDC
0143-9240
11-digit product format
001439240
Labeler code
0143
Product ID
0143-9240_c8047994-3b3a-4e16-809b-786e47014fe9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bleomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065042
Marketing category
ANDA
Marketing start
2018-01-09
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
A065042-001BLEOMYCIN SULFATEBLEOMYCIN SULFATEEQ 30 UNITS BASE/VIALINJECTABLE / INJECTIONAP2001-10-17
A065042-002BLEOMYCIN SULFATEBLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTIONAP2001-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065042-001AP
A065042-002AP

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 22:54:322026-06A065042-001BLEOMYCIN SULFATEEQ 30 UNITS BASE/VIALINJECTABLE / INJECTIONAP2001-10-17a50c72e98297…
2026-08-01 22:54:322026-06A065042-002BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTIONAP2001-10-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065042-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A065042-002AP1a50c72e98297…

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
BleomycinBLEOMYCINHikma Pharmaceuticals USA Inc.cccfb763-79fa-4186-89fb-d8d061d3c1612024-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065042
application number: ANDA065042
ndc (product): 0143-9240

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
cccfb763-79fa-4186-89fb-d8d061d3c161Available 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
0143-9240-01Bleomycin1 in 1 BOX, UNIT-DOSEINJECTION, POWDER, LYOPHILIZED,16
0143-9240-01Bleomycin1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9240-01EA - Each0143-92404dbb0590-33d1-452a-83ad-fb00984d85e812018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9240BLEOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 2 package rows20240413_cccfb763-79fa-4186-89fb-d8d061d3c161.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726673bleomycin 15 UNT InjectionPSNcccfb763-79fa-4186-89fb-d8d061d3c1616
1726676bleomycin 30 UNT InjectionPSNcccfb763-79fa-4186-89fb-d8d061d3c1616
1726673bleomycin 15 UNT InjectionSCDcccfb763-79fa-4186-89fb-d8d061d3c1616
1726676bleomycin 30 UNT InjectionSCDcccfb763-79fa-4186-89fb-d8d061d3c1616
1726673bleomycin (as bleomycin sulfate) 15 UNT InjectionSYcccfb763-79fa-4186-89fb-d8d061d3c1616
1726676bleomycin (as bleomycin sulfate) 30 UNT InjectionSYcccfb763-79fa-4186-89fb-d8d061d3c1616
1726673bleopmycin 15,000 IU InjectionSYcccfb763-79fa-4186-89fb-d8d061d3c1616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9240-01001439240011 VIAL in 1 BOX, UNIT-DOSE (0143-9240-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial2018-01-090000-00-00NoNoCurrent