Ambien CR (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 12.5 mg Tablet Bottle Label

AMBIENCR ®
(ZOLPIDEM TARTRATE EXTENDED-RELEASE) CIV

12.5 mg Tablets

Dispense with Medication Guide

Rx only

55289205 Label
(click image for full-size original)
AMBIEN CR
zolpidem tartrate tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55289-205(NDC:0024-5521)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLPIDEM TARTRATE (ZOLPIDEM) ZOLPIDEM TARTRATE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C BLUE NO. 2
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POTASSIUM BITARTRATE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
SODIUM STARCH GLYCOLATE TYPE A CORN
Product Characteristics
Color blue Score no score
Shape ROUND (Bi-convex round) Size 8mm
Flavor Imprint Code A;
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55289-205-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021774 09/19/2005
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (55289-205)

Revised: 01/2020 PD-Rx Pharmaceuticals, Inc.

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