FDA.reportPublic FDA data

Bleomycin

Product NDC
0703-3154
11-digit product format
007033154
Labeler code
0703
Product ID
0703-3154_2070a6c8-eb51-4e74-abd2-21b2aab55b5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bleomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS
Labeler
Teva Parenteral Medicines, Inc.
Application
ANDA065033
Marketing category
ANDA
Marketing start
2000-06-30
Marketing end
0000-00-00
Substance
BLEOMYCIN SULFATE
Active strength
15 [USP'U]/1
Pharmacologic classes
Cytoprotective Agent [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0703-3154DDiscontinued by firm2026-07-31
excluded packagepackage0703-31540703-3154-01DDiscontinued by firm2026-07-31

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
A065033-001BLEOMYCIN SULFATEBLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2000-06-27
A065033-002BLEOMYCIN SULFATEBLEOMYCIN SULFATEEQ 30 UNITS BASE/VIALINJECTABLE / INJECTION2000-06-27

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 22:54:322026-06A065033-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2000-06-27a50c72e98297…
2026-08-01 22:54:322026-06A065033-002BLEOMYCIN SULFATEEQ 30 UNITS BASE/VIALINJECTABLE / INJECTION2000-06-27a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0703-3154-01EA - Each0703-31547a0e2f6d-2291-4076-abcd-495db887e03d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BLEOMYCIN SULFATEACTIVE INGREDIENT7DP3NTV15TBLEOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TEVA PARENTERAL MEDICINES, INC.]4
BLEOMYCINACTIVE MOIETY40S1VHN69BBLEOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TEVA PARENTERAL MEDICINES, INC.]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0703-3154-01007033154011 VIAL, SINGLE-DOSE in 1 CARTON (0703-3154-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2000-06-300000-00-00NoNoCurrent