FDA.reportPublic FDA data

rifabutin

Product NDC
68180-285
11-digit product format
681800285
Labeler code
68180
Product ID
68180-285_41b20170-81b4-4060-a85d-810249ba2d4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rifabutin
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA090033
Marketing category
ANDA
Marketing start
2014-03-26
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
2023-12-31
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 productproduct68180-285DDiscontinued by firm2026-07-31
excluded packagepackage68180-28568180-285-01DDiscontinued 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
A090033-001RIFABUTINRIFABUTIN150MGCAPSULE / ORAL2014-02-24

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 22:54:322026-06A090033-001RIFABUTIN150MGCAPSULE / ORAL2014-02-24a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68180-285-012025-02-27C16284748780-12cef2736-b05a-d83d-e063-dadaa90ab31fRifabutin Capsules USP, 150 mg Rx only
68180-285-072025-02-27C16284748780-12cef2736-b05a-d83d-e063-dadaa90ab31fRifabutin Capsules USP, 150 mg Rx only
68180-285-012025-01-30C16284748780-12cef2736-b05a-d83d-e063-dadaa90ab31fRifabutin Capsules USP, 150 mg Rx only
68180-285-072025-01-30C16284748780-12cef2736-b05a-d83d-e063-dadaa90ab31fRifabutin Capsules USP, 150 mg Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-285-01EA - Each68180-285153babaf-fced-4a4d-8525-30134ffcf35a12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIFABUTINACTIVE INGREDIENT1W306TDA6SRIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
RIFABUTINACTIVE MOIETY1W306TDA6SRIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKRIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LRIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TRIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71ORIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-285RIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.]11Legacy NDC20250302_4be9cc3f-0016-4426-a700-574b45ce245b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-285-0168180028501100 CAPSULE in 1 BOTTLE (68180-285-01) 100 capsule2014-03-260000-00-00NoNoCurrent
68180-285-076818002850760 CAPSULE in 1 BOTTLE (68180-285-07) 60 capsule2014-03-260000-00-00NoNoCurrent