Mecamylamine Hydrochloride
MECAMYLAMINE Hydrochloride Tablets, USP, 2.5 mg
Approved
Approval ID
b87994ee-26a5-4d00-99e7-796bc17961f1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 4, 2019
Manufacturers
FDA
Nexgen Pharma, Inc.
DUNS: 048488621
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mecamylamine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0722-7183
Application NumberANDA204054
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mecamylamine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 4, 2019
FDA Product Classification
INGREDIENTS (9)
Mecamylamine HydrochlorideActive
Quantity: 2.5 mg in 1 1
Code: 4956DJR58O
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT