Ambien (Page 6 of 6)

REPACKAGING INFORMATION

Please reference the HOW SUPPLIED section listed above for a description of individual tablets or capsules. This drug product has been received by A-S Medication Solutions — Libertyville, IL in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from A-S Medication Solutions are listed below:

NDC#Count Strength
50090-0492-365 mg
50090-0493-11010 mg

Repackaged by:

A-S Medication Solutions
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Libertyville, IL 60048

NDC 50090-0492-3

Packaged by:
A-S Medication Solutions Libertyville, IL 60048

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NDC 50090-0493-1

Packaged by:
A-S Medication Solutions Libertyville, IL 60048

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AMBIEN zolpidem tartrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0492(NDC:0024-5401)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
zolpidem tartrate (zolpidem) zolpidem tartrate 5 mg
Inactive Ingredients
Ingredient Name Strength
hypromelloses
lactose
magnesium stearate
cellulose, microcrystalline
polyethylene glycols
titanium dioxide
FD&C Red No. 40
polysorbate 80
Product Characteristics
Color PINK (pink) Score no score
Shape OVAL (CAPSULE-SHAPED) Size 10mm
Flavor Imprint Code AMB;5;5401
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-0492-3 6 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019908 04/01/1993
AMBIEN zolpidem tartrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0493(NDC:0024-5421)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
zolpidem tartrate (zolpidem) zolpidem tartrate 10 mg
Inactive Ingredients
Ingredient Name Strength
hypromelloses
lactose
magnesium stearate
cellulose, microcrystalline
polyethylene glycols
titanium dioxide
Product Characteristics
Color WHITE (white) Score no score
Shape OVAL (CAPSULE-SHAPED) Size 10mm
Flavor Imprint Code AMB;10;5421
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-0493-1 10 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019908 04/01/1993
Labeler — A-S Medication Solutions LLC (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions LLC 830016429 repack (50090-0492), repack (50090-0493)

Revised: 01/2015 A-S Medication Solutions LLC

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