Zafirlukast
ZAFIRLUKASTTABLETS
Approved
Approval ID
fb546f57-cd2f-4cbf-8c54-fbc23d47fe0f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2019
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
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 Code68151-1977
Application NumberANDA090372
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zafirlukast
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2010
FDA Product Classification
INGREDIENTS (9)
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ZAFIRLUKASTActive
Quantity: 20 mg in 1 1
Code: XZ629S5L50
Classification: ACTIB
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT