MedPath

rifampin

Rifampin Capsules USP

Approved
Approval ID

6d1c87df-b319-4c63-9f19-6584d7c4ff8e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 18, 2024

Manufacturers
FDA

REMEDYREPACK INC.

DUNS: 829572556

Products 1

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

rifampin

PRODUCT DETAILS

NDC Product Code70518-2404
Application NumberANDA090034
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 18, 2024
Generic Namerifampin

INGREDIENTS (13)

CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
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
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
RIFAMPINActive
Quantity: 300 mg in 1 1
Code: VJT6J7R4TR
Classification: ACTIB

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rifampin - FDA Drug Approval Details