FDA.reportPublic FDA data

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

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 159 · 3,165 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
AmoxicillinAMOXICILLINChartwell Governmental & Specialty RX, LLC809393b7-6271-4715-ae84-13fd8f9017722026-07-30Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
HeadacheMELILOTUS OFFICINALIS, SPIGELIA ANTHELMIA, ALLIUM CEPA, BELLADONNA, BRYONIA (ALBA), CIMICIFUGA RACEMOSA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, SANGUINARIA CANADENSIS, SILICEA, TARENTULA CUBENSISBioActive Nutritionals, Inc.918bc478-78a2-41e1-b123-f5350cf8f43a2026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
Prilosec OTCOMEPRAZOLE MAGNESIUMThe Procter & Gamble Manufacturing Company37291cab-e350-d8e3-e063-6294a90a9cb12026-07-29WarningsExact identifier
unii: 426QFE7XLK
AMOXICILLINAMOXICILLINChartwell RX, LLCb07b5ac4-253e-4c83-91c3-3fdc46e91a0f2026-07-24Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals, Inc.4a402dba-c255-5db8-e054-00144ff8d46c2026-07-24Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
amoxicillin and clavulanate potassiumAMOXICILLIN AND CLAVULANATE POTASSIUMChartwell RX, LLC00b86913-50c8-443f-8467-f4f499d358af2026-07-23Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
AmoxicillinAMOXICILLINREMEDYREPACK INC.a2c91cf0-a4e4-44c0-b712-bee63dd6c22b2026-07-22Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
AmoxicillinAMOXICILLINREMEDYREPACK INC.102c62ca-da20-4866-84a8-e3513824af4a2026-07-21Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINREMEDYREPACK INC.9618d038-e880-47f6-b8d7-bbf8ab35364d2026-07-21Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.77b82fac-3f6e-44c9-8dcc-362f01ad7a4b2026-07-21Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.8cb987bf-d45a-c15a-e053-2995a90aad462026-07-21Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.a26f2ceb-bb9b-4813-9691-6343381868602026-07-21Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
RifabutinRIFABUTINMylan Pharmaceuticals Inc.c2026b67-4755-4236-96b6-a6b5e73997072026-07-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 050689
application number: NDA050689
ndc (package): 59762-1350-1
ndc (product): 59762-1350
rxcui: 198200
spl id: acc8cbc0-0202-43e3-a1c2-cc6d960dbb37
spl set id: c2026b67-4755-4236-96b6-a6b5e7399707
unii: 1W306TDA6S

Additional Listing Data#

Finished product
Yes
Brand name base
Rifabutin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIFABUTIN150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1W306TDA6SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198200Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c2026b67-4755-4236-96b6-a6b5e7399707Available on FDA.report

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