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Rifampin

RIFAMPIN CAPSULES, USP

Approved
Approval ID

4ca272ce-2781-4ead-82d2-e7c404533a41

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 4, 2011

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Rifampin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68151-0985
Application NumberANDA065028
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rifampin
Product Specifications
Route of AdministrationORAL
Effective DateMay 16, 2008
FDA Product Classification

INGREDIENTS (17)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
RIFAMPINActive
Quantity: 300 mg in 1 1
Code: VJT6J7R4TR
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT

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Rifampin - FDA Drug Approval Details