Zafirlukast
ZAFIRLUKASTTABLETS
Approved
Approval ID
6ccb96af-2647-9206-5eee-49a825d32488
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2018
Manufacturers
FDA
Dr. Reddys Laboratories Limited
DUNS: 650562841
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Zafirlukast
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55111-625
Application NumberANDA090372
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zafirlukast
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2016
FDA Product Classification
INGREDIENTS (9)
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
ZafirlukastActive
Quantity: 10 mg in 1 1
Code: XZ629S5L50
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Zafirlukast
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55111-626
Application NumberANDA090372
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zafirlukast
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2016
FDA Product Classification
INGREDIENTS (9)
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
ZafirlukastActive
Quantity: 20 mg in 1 1
Code: XZ629S5L50
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT