FDA.reportPublic FDA data

Rifabutin

Product NDC
72319-010
11-digit product format
723190010
Labeler code
72319
Product ID
72319-010_4efa116e-c5b0-d87e-e063-6394a90a5077
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rifabutin
Dosage form
CAPSULE
Route
ORAL
Labeler
i3 Pharmaceuticals, LLC
Application
ANDA212430
Marketing category
ANDA
Marketing start
2026-04-16
Substance
RIFABUTIN
Active strength
150 mg/1
Pharmacologic classes
Rifamycin Antimycobacterial [EPC], Rifamycins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A212430-001RIFABUTINRIFABUTIN150MGCAPSULE / ORALAB2026-03-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212430-001AB

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 22:54:322026-06A212430-001RIFABUTIN150MGCAPSULE / ORALAB2026-03-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212430-001AB1a50c72e98297…

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
RifabutinRIFABUTINA2A Integrated Pharmaceuticals10fb5949-5572-47bd-aaf0-018d9978cad82026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212430
application number: ANDA212430
RifabutinRIFABUTINi3 Pharmaceuticals, LLCfd6062e2-17c8-48f4-a1fe-69ebe410f5832026-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212430
application number: ANDA212430
ndc (product): 72319-010

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
fd6062e2-17c8-48f4-a1fe-69ebe410f583Available 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
72319-010-04Rifabutin100 in 1 BOTTLECAPSULE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72319-010-04EA - Each72319-010b17e3368-5945-4219-b794-9a5610c3b3be12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198200rifabutin 150 MG Oral CapsulePSNfd6062e2-17c8-48f4-a1fe-69ebe410f5836
198200rifabutin 150 MG Oral CapsuleSCDfd6062e2-17c8-48f4-a1fe-69ebe410f5836

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72319-010-0472319001004100 CAPSULE in 1 BOTTLE (72319-010-04) 100 capsule2026-04-16NoNoCurrent