Dexamethasone
DEXAMETHASONE Tablets USP, 1.5 mg Rx Only
Approved
Approval ID
fcc75691-974e-4a67-b9d7-64dde72b5595
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2023
Manufacturers
FDA
Larken Laboratories, Inc.
DUNS: 149484540
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexamethasone 1.5 mg
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68047-702
Application NumberANDA201270
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexamethasone 1.5 mg
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification
INGREDIENTS (6)
DEXAMETHASONEActive
Quantity: 1.5 mg in 1 1
Code: 7S5I7G3JQL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT