Home NDC 71288-106 Bleomycin
Product NDC 71288-106
11-digit product format 712880106
Labeler code 71288
Product ID 71288-106_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 15 [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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205030-001 BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 A205030-002 BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205030-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205030-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP 2018-04-20 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Bleomycin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BLEOMYCIN SULFATE 15 [USP'U]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7DP3NTV15T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1726673 Internal RxNorm lookup 1726676 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71288-106-10 Bleomycin 15 in 1 VIAL, SINGLE-DOSE POWDER, FOR SOLUTION 15 3 71288-106-10 Bleomycin 1 in 1 CARTON POWDER, FOR SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-106 BLEOMYCIN (BLEOMYCIN SULFATE) POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 2 Current NDC, Legacy NDC, 2 package rows 20210626_640602f9-a7df-46f0-a9b1-19c471008bee.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71288-106-10 71288010610 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-106-10) / 15 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2018-08-31 0000-00-00 No No Current