Rifabutin

Product NDC
70518-4594
11-digit product format
705184594
Labeler code
70518
Product ID
70518-4594_4dc43e85-741c-b323-e063-6394a90a0d75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rifabutin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA215041
Marketing category
ANDA
Marketing start
2026-03-24
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
IngredientStrength
RIFABUTIN150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1W306TDA6S
Rxcui198200

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
70518-4594-0Rifabutin60 in 1 BOTTLE, PLASTICCAPSULE601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
70518-4594-07051845940060 CAPSULE in 1 BOTTLE, PLASTIC (70518-4594-0) 60 capsule2026-03-24NoNoHistorical