Zafirlukast
Zafirlukast Tablets 8205921/1017 Rx only
Approved
Approval ID
a60f39f6-d590-4b00-8751-7f12b7ec5385
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2022
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 1
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 Code68084-059
Application NumberANDA090372
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zafirlukast
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2022
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ZAFIRLUKASTActive
Quantity: 20 mg in 1 1
Code: XZ629S5L50
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT