FDA.reportPublic FDA data

Bleomycin

Product NDC
63323-137
11-digit product format
633230137
Labeler code
63323
Product ID
63323-137_93aba071-101f-4610-90fa-27e3635b2c1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BLEOMYCIN SULFATE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA065185
Marketing category
ANDA
Marketing start
2009-02-13
Substance
BLEOMYCIN SULFATE
Active strength
30 [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
A065185-001BLEOMYCIN SULFATEBLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTIONAPRS2008-01-28
A065185-002BLEOMYCIN SULFATEBLEOMYCIN SULFATEEQ 30 UNITS BASE/VIALINJECTABLE / INJECTIONAPRS2008-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065185-001AP
A065185-002AP

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 22:54:322026-06A065185-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTIONAPRS2008-01-28a50c72e98297…
2026-08-01 22:54:322026-06A065185-002BLEOMYCIN SULFATEEQ 30 UNITS BASE/VIALINJECTABLE / INJECTIONAPRS2008-01-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065185-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A065185-002AP1a50c72e98297…

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
BleomycinBLEOMYCIN SULFATEFresenius Kabi USA, LLCb5806c40-12ce-48e3-8abd-9f8997ef44282024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065185
application number: ANDA065185
ndc (product): 63323-137

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BLEOMYCIN SULFATE30 [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
b5806c40-12ce-48e3-8abd-9f8997ef4428Available 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
63323-137-20Bleomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,17
63323-137-20Bleomycin1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-137-20EA - Each63323-137b2db77e0-76a0-495c-9788-b87c165b6b9a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BLEOMYCIN SULFATEACTIVE INGREDIENT7DP3NTV15TBLEOMYCIN (BLEOMYCIN SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
BLEOMYCINACTIVE MOIETY40S1VHN69BBLEOMYCIN (BLEOMYCIN SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-137BLEOMYCIN (BLEOMYCIN SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 2 package rows20241013_b5806c40-12ce-48e3-8abd-9f8997ef4428.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726673bleomycin 15 UNT InjectionPSNb5806c40-12ce-48e3-8abd-9f8997ef44287
1726676bleomycin 30 UNT InjectionPSNb5806c40-12ce-48e3-8abd-9f8997ef44287
1726673bleomycin 15 UNT InjectionSCDb5806c40-12ce-48e3-8abd-9f8997ef44287
1726676bleomycin 30 UNT InjectionSCDb5806c40-12ce-48e3-8abd-9f8997ef44287
1726673bleomycin (as bleomycin sulfate) 15 UNT InjectionSYb5806c40-12ce-48e3-8abd-9f8997ef44287
1726676bleomycin (as bleomycin sulfate) 30 UNT InjectionSYb5806c40-12ce-48e3-8abd-9f8997ef44287
1726673bleopmycin 15,000 IU InjectionSYb5806c40-12ce-48e3-8abd-9f8997ef44287

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-137-20633230137201 VIAL in 1 CARTON (63323-137-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial2009-02-130000-00-00NoNoCurrent