ZOLPIDEM TARTRATE (Page 7 of 7)

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma — TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count5mg
1043353-242-10
1443353-242-14
1543353-242-15
2043353-242-20
2243353-242-59
2843353-242-28
3043353-242-30
4543353-242-45
6043353-242-53
9043353-242-60
Count10mg
1043353-243-10
1443353-243-14
1543353-243-15
2043353-243-20
2243353-243-59
2843353-243-28
3043353-243-30
4543353-242-45
6043353-243-53
9043353-243-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions -- TN
Cookeville, TN 38506
20171017JH

PRINCIPAL DISPLAY PANEL — 5mg

NDC 43353-242 — Zolpidem Tartrate, USP 5mg — Rx Only

Bottle Label 5mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10mg

NDC 43353-243 — Zolpidem Tartrate, USP 10mg — Rx Only

Bottle Label 10mg
(click image for full-size original)

ZOLPIDEM TARTRATE zolpidem tartrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43353-242(NDC:13668-007)
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
FERRIC OXIDE RED
Product Characteristics
Color red (Red) Score no score
Shape CAPSULE (Capsule) Size 10mm
Flavor Imprint Code 5MG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43353-242-10 10 TABLET in 1 BOTTLE None
2 NDC:43353-242-14 14 TABLET in 1 BOTTLE None
3 NDC:43353-242-15 15 TABLET in 1 BOTTLE None
4 NDC:43353-242-20 20 TABLET in 1 BOTTLE None
5 NDC:43353-242-59 22 TABLET in 1 BOTTLE None
6 NDC:43353-242-28 28 TABLET in 1 BOTTLE None
7 NDC:43353-242-30 30 TABLET in 1 BOTTLE None
8 NDC:43353-242-45 45 TABLET in 1 BOTTLE None
9 NDC:43353-242-53 60 TABLET in 1 BOTTLE None
10 NDC:43353-242-60 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077903 09/05/2007
ZOLPIDEM TARTRATE zolpidem tartrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43353-243(NDC:13668-008)
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
FERRIC OXIDE RED
Product Characteristics
Color yellow (peach-yellow) Score no score
Shape CAPSULE (Capsule) Size 10mm
Flavor Imprint Code 10MG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43353-243-10 10 TABLET in 1 BOTTLE None
2 NDC:43353-243-14 14 TABLET in 1 BOTTLE None
3 NDC:43353-243-15 15 TABLET in 1 BOTTLE None
4 NDC:43353-243-20 20 TABLET in 1 BOTTLE None
5 NDC:43353-243-59 22 TABLET in 1 BOTTLE None
6 NDC:43353-243-28 28 TABLET in 1 BOTTLE None
7 NDC:43353-243-30 30 TABLET in 1 BOTTLE None
8 NDC:43353-243-45 45 TABLET in 1 BOTTLE None
9 NDC:43353-243-53 60 TABLET in 1 BOTTLE None
10 NDC:43353-243-60 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077903 09/05/2007
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (43353-242), REPACK (43353-243)

Revised: 12/2019 Aphena Pharma Solutions — Tennessee, LLC

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