MedPath

Rifampin

RIFAMPIN CAPSULES, USP

Approved
Approval ID

26a2dbca-5090-4f6c-99ed-e11a70bb5af0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 12, 2022

Manufacturers
FDA

Akorn

DUNS: 117693100

Products 2

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 Code61748-015
Application NumberANDA065028
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rifampin
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2022
FDA Product Classification

INGREDIENTS (17)

SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
RIFAMPINActive
Quantity: 150 mg in 1 1
Code: VJT6J7R4TR
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT

Rifampin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61748-018
Application NumberANDA065028
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rifampin
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2022
FDA Product Classification

INGREDIENTS (17)

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

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