Home NDC 10135-738 Rifabutin
Product NDC 10135-738
11-digit product format 101350738
Labeler code 10135
Product ID 10135-738_43e1cc33-400c-6f7d-e063-6394a90ab38d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rifabutin
Dosage form CAPSULE
Route ORAL
Labeler Marlex Pharmaceuticals, Inc.
Application ANDA215041
Marketing category ANDA
Marketing start 2022-05-01
Substance RIFABUTIN
Active strength 150 mg/1
Pharmacologic classes Rifamycin Antimycobacterial [EPC], Rifamycins [CS]
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 43 .
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 A215041-001 RIFABUTIN RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215041-001 AB
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 2026-09-14 22:38:34 2026-08 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215041-001 RIFABUTIN 150MG CAPSULE / ORAL AB 2021-12-17 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Rifabutin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIFABUTIN 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1W306TDA6S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198200 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 10135-738-01 Rifabutin 100 in 1 BOTTLE CAPSULE 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-738 RIFABUTIN CAPSULE [MARLEX PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20241018_df7d4103-42e4-4e4f-e053-2a95a90a8ce8.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 · 3 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 10135-738-01 10135073801 100 CAPSULE in 1 BOTTLE (10135-738-01) 100 capsule 2022-05-01 0000-00-00 No No Current