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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RIFABUTIN	150 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	1W306TDA6S
Rxcui	198200

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
48b3639b-9f6e-fb03-0720-42e7d1e139ac	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72319-010-04	Rifabutin	100 in 1 BOTTLE	CAPSULE	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72319-010-04	EA - Each	72319-010	b17e3368-5945-4219-b794-9a5610c3b3be	1	2026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198200	rifabutin 150 MG Oral Capsule	PSN	fd6062e2-17c8-48f4-a1fe-69ebe410f583	6
198200	rifabutin 150 MG Oral Capsule	SCD	fd6062e2-17c8-48f4-a1fe-69ebe410f583	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72319-010-04	72319001004	100 CAPSULE in 1 BOTTLE (72319-010-04)	100 capsule	2026-04-16	No	No	Historical