FDA.reportPublic FDA data

Rifabutin

Product NDC
70954-041
11-digit product format
709540041
Labeler code
70954
Product ID
70954-041_cc04157f-1cc1-4f4a-a77f-9042a99e7825
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rifabutin
Dosage form
CAPSULE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA215041
Marketing category
ANDA
Marketing start
2021-12-17
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
A215041-001RIFABUTINRIFABUTIN150MGCAPSULE / ORALAB2021-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215041-001AB

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 22:54:322026-06A215041-001RIFABUTIN150MGCAPSULE / ORALAB2021-12-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A215041-001AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RifabutinRIFABUTINREMEDYREPACK INC.754d2d7f-f0db-4f89-8fcd-5e2ff52d50302026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215041
application number: ANDA215041
RifabutinRIFABUTINMarlex Pharmaceuticals, Inc.df7d4103-42e4-4e4f-e053-2a95a90a8ce82025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215041
application number: ANDA215041
RifabutinRIFABUTINANI Pharmaceuticals, Inc.baf8ec98-bd0c-4b87-a7ee-813335431b892025-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215041
application number: ANDA215041
ndc (product): 70954-041

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 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
baf8ec98-bd0c-4b87-a7ee-813335431b89Available 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
70954-041-10Rifabutin100 in 1 BOTTLECAPSULE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-041-10EA - Each70954-04154017396-ee9e-4e9f-9a45-c32933a4bc8612022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-041RIFABUTIN CAPSULE [ANI PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 1 package rows20250410_baf8ec98-bd0c-4b87-a7ee-813335431b89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198200rifabutin 150 MG Oral CapsulePSNdf7d4103-42e4-4e4f-e053-2a95a90a8ce84
198200rifabutin 150 MG Oral CapsuleSCDdf7d4103-42e4-4e4f-e053-2a95a90a8ce84
198200rifabutin 150 MG Oral CapsulePSNbaf8ec98-bd0c-4b87-a7ee-813335431b892
198200rifabutin 150 MG Oral CapsuleSCDbaf8ec98-bd0c-4b87-a7ee-813335431b892
198200rifabutin 150 MG Oral CapsulePSN754d2d7f-f0db-4f89-8fcd-5e2ff52d50301
198200rifabutin 150 MG Oral CapsuleSCD754d2d7f-f0db-4f89-8fcd-5e2ff52d50301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-041-1070954004110100 CAPSULE in 1 BOTTLE (70954-041-10) 100 capsule2021-12-170000-00-00NoNoCurrent