Vecamyl (Page 2 of 2)

HOW SUPPLIED

VecamylTM [Mecamylamine HCl Tablet USP] are slightly yellow, round, compressed tablets, coded MP on one side and 2.5 on the other side. They are supplied as follows:

NDC 45043-558-40 in bottles of 100.

STORAGE CONDITION

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
[see USP Controlled Room [Temperature]

Manufactured by: Nexgen Pharma, Inc. Colorado Springs, CO 80906

7183 Rev.09/12

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Vecamyl Container Label
(click image for full-size original)

100 Count Container Label

100 Count Container Label

VECAMYL
mecamylamine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45043-558
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mecamylamine Hydrochloride (Mecamylamine) Mecamylamine Hydrochloride 2.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
STARCH, CORN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
Talc
Water
Product Characteristics
Color YELLOW (YELLOW) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code MP;2;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45043-558-40 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204054 03/19/2013
Labeler — Manchester Pharmaceuticals (832417641)
Registrant — Manchester Pharmaceuticals (832417641)
Establishment
Name Address ID/FEI Operations
Nexgen Pharma, Inc. 806784679 MANUFACTURE (45043-558), ANALYSIS (45043-558), PACK (45043-558), LABEL (45043-558)

Revised: 07/2015 Manchester Pharmaceuticals

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