Home NDC 0013-5301 Mycobutin
Product NDC 0013-5301
11-digit product format 000135301
Labeler code 0013
Product ID 0013-5301_47f0a676-c541-4d24-8710-bef6180556e3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rifabutin
Dosage form CAPSULE
Route ORAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA050689
Marketing category NDA
Marketing start 1992-12-23
Marketing end 0000-00-00
Substance RIFABUTIN
Active strength 150 mg/1
Pharmacologic classes Rifamycin Antimycobacterial [EPC],Rifamycins [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 0013-5301 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0013-5301 0013-5301-17 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RIFABUTIN ACTIVE INGREDIENT 1W306TDA6S MYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY] 12 RIFABUTIN ACTIVE MOIETY 1W306TDA6S MYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY] 12 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY] 12 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY] 12 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY] 12 RIFABUTIN ACTIVE INGREDIENT 1W306TDA6S MYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 RIFABUTIN ACTIVE MOIETY 1W306TDA6S MYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0013-5301 MYCOBUTIN (RIFABUTIN) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC] 24 Legacy NDC 20241225_3e1a6613-bdd3-4261-93b3-d7f5cc09064b.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 0013-5301-17 00013530117 100 CAPSULE in 1 BOTTLE (0013-5301-17) 100 capsule 1992-12-23 0000-00-00 No No Current