Gabapentin: Package Insert and Label Information (Page 5 of 5)

Manufactured by:
Amneal Pharmaceuticals of NY
Hauppauge, NY 11788

Distributed by:
Amneal Pharmaceuticals Glasgow, KY 42141

Rev. 10-2011

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GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-708(NDC:53746-102)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 300 mg
Product Characteristics
Color YELLOW (Buff-Buff) Score no score
Shape CAPSULE (HARD GELATIN) Size 19mm
Flavor Imprint Code IP102
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35356-708-30 30 CAPSULE in 1 BOTTLE None
2 NDC:35356-708-60 60 CAPSULE in 1 BOTTLE None
3 NDC:35356-708-90 90 CAPSULE in 1 BOTTLE None
4 NDC:35356-708-01 120 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078428 11/24/2009
Labeler — Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC (831276758)
Establishment
Name Address ID/FEI Operations
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 831276758 repack (35356-708)

Revised: 07/2019 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

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