FDA.reportPublic FDA data

Mycobutin

Product NDC
55695-010
11-digit product format
556950010
Labeler code
55695
Product ID
55695-010_2dcafbab-386d-2716-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rifabutin
Dosage form
CAPSULE
Route
ORAL
Labeler
Department of State Health Services, Pharmacy Branch
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55695-010IInactivated by FDA2026-07-31
excluded packagepackage55695-01055695-010-00IInactivated by FDA2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050689-001MYCOBUTINRIFABUTIN150MGCAPSULE / ORALABRLD, RS1992-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N050689-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N050689-001MYCOBUTIN150MGCAPSULE / ORALABRLD, RS1992-12-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N050689-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RifabutinRIFABUTINMylan Pharmaceuticals Inc.c2026b67-4755-4236-96b6-a6b5e73997072026-07-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 050689
application number: NDA050689
RifabutinRIFABUTINREMEDYREPACK INC.25a60937-cbbe-4a50-994f-2ce15203f5892025-09-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 050689
application number: NDA050689

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
48b3639b-9f6e-fb03-0720-42e7d1e139acProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55695-010-002020-01-31C16284748780-19d75b9d0-b611-f424-e053-dadaa90a57ceMycobutin ® (Rifabutin) Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55695-010-00Mycobutin100 in 1 BOTTLECAPSULE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55695-010MYCOBUTIN (RIFABUTIN) CAPSULE [DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH]1Legacy NDC, 1 package rows20160316_2e050d5e-3175-2c6d-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103899Mycobutin 150 MG Oral CapsulePSN2e050d5e-3175-2c6d-e054-00144ff88e881
198200rifabutin 150 MG Oral CapsulePSN2e050d5e-3175-2c6d-e054-00144ff88e881
103899rifabutin 150 MG Oral Capsule [Mycobutin]SBD2e050d5e-3175-2c6d-e054-00144ff88e881
198200rifabutin 150 MG Oral CapsuleSCD2e050d5e-3175-2c6d-e054-00144ff88e881
103899Mycobutin 150 MG Oral CapsuleSY2e050d5e-3175-2c6d-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55695-010-0055695001000100 in 1 BOTTLEHistorical