Home NDC 70518-4254 Rifabutin
Product NDC 70518-4254
11-digit product format 705184254
Labeler code 70518
Product ID 70518-4254_40089d1e-2431-3042-e063-6394a90afb4a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rifabutin
Dosage form CAPSULE
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA050689
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2025-01-13
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 N050689-001 MYCOBUTIN RIFABUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050689-001 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.
Product history page 1 of 2 · 43 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 2026-09-14 22:38:34 2026-08 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050689-001 MYCOBUTIN 150MG CAPSULE / ORAL AB RLD, RS 1992-12-23 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Rifabutin
Listing expiration 2027-12-31 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 70518-4254-0 Rifabutin 60 in 1 BOTTLE, PLASTIC CAPSULE 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4254 RIFABUTIN CAPSULE [REMEDYREPACK INC.] 1 Current NDC, 1 package rows 20250114_25a60937-cbbe-4a50-994f-2ce15203f589.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 Sample Exclude flag Status 70518-4254-0 70518425400 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-4254-0) 60 capsule 2025-01-13 No No Current