FDA.reportPublic FDA data

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

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 productproduct0013-5301DDiscontinued by firm2026-07-31
excluded packagepackage0013-53010013-5301-17DDiscontinued by firm2026-07-31

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0013-5301-17EA - Each0013-5301501d253c-45f6-4e0a-a5d2-dc05f1134dd012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIFABUTINACTIVE INGREDIENT1W306TDA6SMYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY]12
RIFABUTINACTIVE MOIETY1W306TDA6SMYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY]12
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY]12
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYCOBUTIN (RIFABUTIN) CAPSULE [PHARMACIA AND UPJOHN COMPANY]12
RIFABUTINACTIVE INGREDIENT1W306TDA6SMYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
RIFABUTINACTIVE MOIETY1W306TDA6SMYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMYCOBUTIN (RIFABUTIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0013-5301MYCOBUTIN (RIFABUTIN) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]24Legacy NDC20241225_3e1a6613-bdd3-4261-93b3-d7f5cc09064b.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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0013-5301-1700013530117100 CAPSULE in 1 BOTTLE (0013-5301-17) 100 capsule1992-12-230000-00-00NoNoCurrent