Home NDC 71288-158 Busulfan
Product NDC 71288-158
11-digit product format 712880158
Labeler code 71288
Product ID 71288-158_598cecaa-f38c-451c-a3c8-55d90401b742
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Busulfan
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA212127
Marketing category ANDA
Marketing start 2020-10-23
Substance BUSULFAN
Active strength 6 mg/mL
Pharmacologic classes Alkylating Activity [MoA], Alkylating Drug [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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212127-001 BUSULFAN BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212127-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212127-001 BUSULFAN 6MG/ML INJECTABLE / INJECTION AP 2020-10-23 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Busulfan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUSULFAN 6 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G1LN9045DK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 253113 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 71288-158-95 Busulfan 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 1 71288-158-96 Busulfan 8 in 1 CARTON INJECTION, SOLUTION 8 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-158 BUSULFAN INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 1 Current NDC, Legacy NDC, 2 package rows 20210615_dc384f16-4e25-458e-874c-553f81c6d8c9.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 Units Marketing start Marketing end Sample Exclude flag Status 71288-158-95 71288015895 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 71288-158-96 71288015896 8 VIAL, SINGLE-DOSE in 1 CARTON (71288-158-96) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-158-95) 2020-10-23 0000-00-00 No No Current