NDC | 60760-605-30, 60760-605-60, 60760-605-90 |
Set ID | 6141b3a6-fcaa-1a06-e053-2991aa0ac7c4 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | St. Mary’s Medical Park Pharmacy |
Generic Name | |
Product Class | Anti-epileptic Agent |
Product Number | |
Application Number | ANDA090007 |
- HOW SUPPLIED
- MEDICATION GUIDE
- 100 mg Gabapentin Capsule Package Labels
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INGREDIENTS AND APPEARANCE
GABAPENTIN
gabapentin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60760-605(NDC:49483-605) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN 100 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) GELATIN (UNII: 2G86QN327L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) Product Characteristics Color white Score no score Shape CAPSULE Size 16mm Flavor Imprint Code 103 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60760-605-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/26/2017 2 NDC:60760-605-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/29/2017 3 NDC:60760-605-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/13/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090007 12/26/2017 Labeler - St. Mary’s Medical Park Pharmacy (063050751) Establishment Name Address ID/FEI Business Operations St. Mary’s Medical Park Pharmacy 063050751 repack(60760-605) , relabel(60760-605) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(60760-605)