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Rifampin

Rifampin Capsules, USP

Approved
Approval ID

9498a2f4-6b05-4811-80d7-9acaa9cf59a5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 17, 2011

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 2

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

Rifampin

PRODUCT DETAILS

NDC Product Code54868-4683
Application NumberANDA065390
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 30, 2011
Generic NameRifampin

INGREDIENTS (16)

ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
RIFAMPINActive
Quantity: 300 mg in 1 1
Code: VJT6J7R4TR
Classification: ACTIB
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT

Rifampin

PRODUCT DETAILS

NDC Product Code54868-5472
Application NumberANDA065390
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 30, 2011
Generic NameRifampin

INGREDIENTS (16)

RIFAMPINActive
Quantity: 150 mg in 1 1
Code: VJT6J7R4TR
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
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Rifampin - FDA Approval | MedPath