FDA.reportPublic FDA data

Bleomycin

Product NDC
71288-107
11-digit product format
712880107
Labeler code
71288
Product ID
71288-107_322a4cec-4797-49a9-b880-ea80fdb133f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bleomycin Sulfate
Dosage form
POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA205030
Marketing category
ANDA
Marketing start
2018-08-31
Substance
BLEOMYCIN SULFATE
Active strength
30 [USP'U]/1
Pharmacologic classes
Cytoprotective Agent [EPC]
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
A205030-001BLEOMYCIN SULFATEBLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTIONAP2018-04-20
A205030-002BLEOMYCIN SULFATEBLEOMYCIN SULFATEEQ 30 UNITS BASE/VIALINJECTABLE / INJECTIONAP2018-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205030-001AP
A205030-002AP

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 22:54:322026-06A205030-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTIONAP2018-04-20a50c72e98297…
2026-08-01 22:54:322026-06A205030-002BLEOMYCIN SULFATEEQ 30 UNITS BASE/VIALINJECTABLE / INJECTIONAP2018-04-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205030-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A205030-002AP1a50c72e98297…

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
BleomycinBLEOMYCIN SULFATEMeitheal Pharmaceuticals Inc.640602f9-a7df-46f0-a9b1-19c471008bee2026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205030
application number: ANDA205030
ndc (product): 71288-107
BleomycinBLEOMYCINNorthStar Rx LLC6824b1e1-e5fa-4371-ade9-1346e12ab0c72026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205030
application number: ANDA205030

Additional Listing Data#

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

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
640602f9-a7df-46f0-a9b1-19c471008beeAvailable 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
71288-107-20Bleomycin1 in 1 CARTONPOWDER, FOR SOLUTION13
71288-107-20Bleomycin30 in 1 VIAL, SINGLE-DOSEPOWDER, FOR SOLUTION303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-107-20EA - Each71288-107b1887174-87de-4fb8-ab0f-21a6f0aef99312018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-107BLEOMYCIN (BLEOMYCIN SULFATE) POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 2 package rows20210626_640602f9-a7df-46f0-a9b1-19c471008bee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726673bleomycin 15 UNT InjectionPSN640602f9-a7df-46f0-a9b1-19c471008bee3
1726676bleomycin 30 UNT InjectionPSN640602f9-a7df-46f0-a9b1-19c471008bee3
1726673bleomycin 15 UNT InjectionSCD640602f9-a7df-46f0-a9b1-19c471008bee3
1726676bleomycin 30 UNT InjectionSCD640602f9-a7df-46f0-a9b1-19c471008bee3
1726673bleomycin (as bleomycin sulfate) 15 UNT InjectionSY640602f9-a7df-46f0-a9b1-19c471008bee3
1726676bleomycin (as bleomycin sulfate) 30 UNT InjectionSY640602f9-a7df-46f0-a9b1-19c471008bee3
1726673bleopmycin 15,000 IU InjectionSY640602f9-a7df-46f0-a9b1-19c471008bee3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-107-20712880107201 VIAL, SINGLE-DOSE in 1 CARTON (71288-107-20) / 30 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2018-08-310000-00-00NoNoCurrent