FDA.reportPublic FDA data

Rifampin

Product NDC
52959-653
11-digit product format
529590653
Labeler code
52959
Product ID
52959-653_0a0823ba-8547-46bb-84de-076196f6a913
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rifampin
Dosage form
CAPSULE, COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA065028
Marketing category
ANDA
Marketing start
2001-07-01
Marketing end
0000-00-00
Substance
RIFAMPIN
Active strength
300 mg/1
Pharmacologic classes
Rifamycin Antibacterial [EPC],Rifamycins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
29eec95f-f163-42e8-88a8-3cb43899b2b7Product name320160405
26abd97e-907b-0cb8-84ee-99fb15297adaProduct name120140508
7cf7f62d-3767-728f-c117-96e96c1ed8bfProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-653-102019-11-13C16284748780-197449f38-c91a-f6ea-e053-dbdaa90aa703RIFAMPIN CAPSULES, USP
52959-653-202019-11-13C16284748780-197449f38-c91a-f6ea-e053-dbdaa90aa703RIFAMPIN CAPSULES, USP
52959-653-302019-11-13C16284748780-197449f38-c91a-f6ea-e053-dbdaa90aa703RIFAMPIN CAPSULES, USP
52959-653-402019-11-13C16284748780-197449f38-c91a-f6ea-e053-dbdaa90aa703RIFAMPIN CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-653-10Rifampin10 in 1 BOTTLE, PLASTICCAPSULE, COATED102
52959-653-20Rifampin20 in 1 BOTTLE, PLASTICCAPSULE, COATED202
52959-653-30Rifampin30 in 1 BOTTLE, PLASTICCAPSULE, COATED302
52959-653-40Rifampin40 in 1 BOTTLE, PLASTICCAPSULE, COATED402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-653-10EA - Each52959-65372e3ecdc-37b7-45f4-8553-af4099b7955612012-07-24
52959-653-20EA - Each52959-653a7abe3da-d74b-46fb-bdf4-7294c1d5823712012-07-24
52959-653-30EA - Each52959-653405697e3-3233-4b44-b43b-f54662613ed112012-07-24
52959-653-40EA - Each52959-653039dda10-6687-44d6-a7c4-3e437e3f7ac612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIFAMPINACTIVE INGREDIENTVJT6J7R4TRRIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2
RIFAMPINACTIVE MOIETYVJT6J7R4TRRIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XRIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ORIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LRIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71ORIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1URIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-653RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 4 package rows20120120_3cc0bcd2-37d7-4a7b-808b-980d864281af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198202rifAMPin 300 MG Oral CapsulePSN3cc0bcd2-37d7-4a7b-808b-980d864281af2
198202rifampin 300 MG Oral CapsuleSCD3cc0bcd2-37d7-4a7b-808b-980d864281af2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-653-105295906531010 in 1 BOTTLE, PLASTICHistorical
52959-653-205295906532020 in 1 BOTTLE, PLASTICHistorical
52959-653-305295906533030 in 1 BOTTLE, PLASTICHistorical
52959-653-405295906534040 in 1 BOTTLE, PLASTICHistorical