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Pirfenidone

PIRFENIDONE CAPSULES safely and effectively. See full prescribing information for PIRFENIDONE CAPSULES.

Approved
Approval ID

ea26490e-fd32-4807-8556-eb6f5f963c23

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 17, 2023

Manufacturers
FDA

Amneal Pharmaceuticals NY LLC

DUNS: 123797875

Products 1

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

Pirfenidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69238-1642
Application NumberANDA212569
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pirfenidone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 17, 2023
FDA Product Classification

INGREDIENTS (16)

BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PIRFENIDONEActive
Quantity: 267 mg in 1 1
Code: D7NLD2JX7U
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Pirfenidone - FDA Drug Approval Details