Home NDC 63323-136 Bleomycin
Product NDC 63323-136
11-digit product format 633230136
Labeler code 63323
Product ID 63323-136_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 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 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 A065185-001 BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 A065185-002 BLEOMYCIN SULFATE BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28
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 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065185-001 BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065185-002 BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL INJECTABLE / INJECTION AP RS 2008-01-28 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 2026-12-31 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 63323-136-10 Bleomycin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 7 63323-136-10 Bleomycin 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BLEOMYCIN SULFATE ACTIVE INGREDIENT 7DP3NTV15T BLEOMYCIN (BLEOMYCIN SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4 BLEOMYCIN ACTIVE MOIETY 40S1VHN69B BLEOMYCIN (BLEOMYCIN SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-136 BLEOMYCIN (BLEOMYCIN SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 7 Current NDC, Legacy NDC, 2 package rows 20241013_b5806c40-12ce-48e3-8abd-9f8997ef4428.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-136-10 63323013610 1 VIAL in 1 CARTON (63323-136-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 1 vial 2009-02-13 0000-00-00 No No Current