NDC | 68071-3230-1, 68071-3230-2, 68071-3230-3, 68071-3230-4, 68071-3230-5, 68071-3230-6, 68071-3230-7, 68071-3230-8, 68071-3230-9 |
Set ID | 4fe85b34-8fe8-56fa-e054-00144ff88e88 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | NuCare Pharmaceuticals, Inc. |
Generic Name | |
Product Class | Anti-epileptic Agent |
Product Number | |
Application Number | ANDA090007 |
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HOW SUPPLIED
300 mg Capsules (Yellow/Yellow colored, size '1' hard gelatin capsules with "104" printed on body of capsules containing white to off white granular powder Bottles of 7 NDC 68071-3230-7
Bottles of 14 NDC 68071-3230-5
Bottles of 30 NDC 68071-3230-3
Bottles of 60 NDC 68071-3230-6
Bottles of 84 NDC 68071-3230-4
Bottles of 90 NDC 68071-3230-9
Bottles of 120 NDC 68071-3230-1
Bottles of 180 NDC 68071-3230-8
Bottles of 270 NDC 68071-3230-2
- 300mg Gabapentin Capsule Package Label
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INGREDIENTS AND APPEARANCE
GABAPENTIN
gabapentin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-3230(NDC:49483-606) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN 300 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) GELATIN (UNII: 2G86QN327L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) Product Characteristics Color yellow Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 104 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-3230-7 7 in 1 BOTTLE; Type 0: Not a Combination Product 05/19/2017 2 NDC:68071-3230-5 14 in 1 BOTTLE; Type 0: Not a Combination Product 05/19/2017 3 NDC:68071-3230-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/19/2017 4 NDC:68071-3230-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 05/19/2017 5 NDC:68071-3230-4 84 in 1 BOTTLE; Type 0: Not a Combination Product 05/19/2017 6 NDC:68071-3230-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/19/2017 7 NDC:68071-3230-1 120 in 1 BOTTLE; Type 0: Not a Combination Product 05/19/2017 8 NDC:68071-3230-8 180 in 1 BOTTLE; Type 0: Not a Combination Product 05/19/2017 9 NDC:68071-3230-2 270 in 1 BOTTLE; Type 0: Not a Combination Product 05/19/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090007 12/30/2015 Labeler - NuCare Pharmaceuticals, Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals, Inc. 010632300 repack(68071-3230)