Rifabutin

Product NDC
59762-1350
11-digit product format
597621350
Labeler code
59762
Product ID
59762-1350_25e74b16-cdf0-4959-be62-1745c4e4cf0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rifabutin
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA050689
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-04-07
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

Additional Listing Data#

Finished product
Yes
Brand name base
Rifabutin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIFABUTIN150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1W306TDA6S
Rxcui198200

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-1350-1Rifabutin100 in 1 BOTTLECAPSULE10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-1350-1EA - Each59762-1350deebd49a-92e1-4774-9b81-6edce914cba512014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIFABUTINACTIVE INGREDIENT1W306TDA6SRIFABUTIN CAPSULE [GREENSTONE LLC]3
RIFABUTINACTIVE MOIETY1W306TDA6SRIFABUTIN CAPSULE [GREENSTONE LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIFABUTIN CAPSULE [GREENSTONE LLC]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RIFABUTIN CAPSULE [GREENSTONE LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIFABUTIN CAPSULE [GREENSTONE LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RIFABUTIN CAPSULE [GREENSTONE LLC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRIFABUTIN CAPSULE [GREENSTONE LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRIFABUTIN CAPSULE [GREENSTONE LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-1350RIFABUTIN CAPSULE [MYLAN PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 1 package rows20250523_c2026b67-4755-4236-96b6-a6b5e7399707.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198200rifabutin 150 MG Oral CapsulePSNc2026b67-4755-4236-96b6-a6b5e739970713
198200rifabutin 150 MG Oral CapsuleSCDc2026b67-4755-4236-96b6-a6b5e739970713
198200rifabutin 150 MG Oral CapsulePSN25a60937-cbbe-4a50-994f-2ce15203f5895
198200rifabutin 150 MG Oral CapsuleSCD25a60937-cbbe-4a50-994f-2ce15203f5895

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-1350-159762135001100 CAPSULE in 1 BOTTLE (59762-1350-1) 100 capsule2014-04-070000-00-00NoNoCurrent