NDC 45865-347

Gabapentin

Gabapentin

Gabapentin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Medsource Pharmaceuticals. The primary component is Gabapentin.

• Product ID: 45865-347_62717c61-b047-49f2-ab29-a852dc5dead2
• NDC: 45865-347
• Product Type: Human Prescription Drug
• Proprietary Name: Gabapentin
• Generic Name: Gabapentin
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2009-11-24
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078428
• Labeler Name: Medsource Pharmaceuticals
• Substance Name: GABAPENTIN
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 45865-347-30

30 CAPSULE in 1 BOTTLE (45865-347-30)

• Marketing Start Date: 2009-11-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45865-347-49 [45865034749]

Gabapentin CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA078428
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-11-24
• Inactivation Date: 2019-11-13

NDC 45865-347-57 [45865034757]

Gabapentin CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA078428
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-11-24
• Inactivation Date: 2019-11-13

NDC 45865-347-60 [45865034760]

Gabapentin CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA078428
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-11-24
• Inactivation Date: 2019-11-13

NDC 45865-347-30 [45865034730]

Gabapentin CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA078428
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-11-24
• Inactivation Date: 2019-11-13

NDC 45865-347-90 [45865034790]

Gabapentin CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA078428
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-11-24
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
GABAPENTIN	300 mg/1

OpenFDA Data

• SPL SET ID: 119ff7cc-5a38-490a-a982-7431b34d061c
• Manufacturer:
  • Medsource Pharmaceuticals
• UNII:
  • 6CW7F3G59X
• RxNorm Concept Unique ID - RxCUI:
  • 310431

Pharmacological Class

• Anti-epileptic Agent [EPC]
• Decreased Central Nervous System Disorganized Electrical Activity [PE]

NDC Crossover Matching brand name "Gabapentin" or generic name "Gabapentin"

NDC	Brand Name	Generic Name
0093-4443	Gabapentin	Gabapentin
0093-4444	Gabapentin	Gabapentin
0143-3991	Gabapentin	Gabapentin
0143-3993	Gabapentin	Gabapentin
0143-3994	Gabapentin	Gabapentin
0143-9992	Gabapentin	Gabapentin
0143-9993	Gabapentin	Gabapentin
0143-9994	Gabapentin	Gabapentin
67877-222	Gabapentin	Gabapentin
67877-223	Gabapentin	Gabapentin
67877-224	Gabapentin	Gabapentin
67877-428	Gabapentin	Gabapentin
67877-429	Gabapentin	Gabapentin
68001-006	Gabapentin	Gabapentin
68001-007	Gabapentin	Gabapentin
68071-1212	GABAPENTIN	GABAPENTIN
68071-1292	Gabapentin	Gabapentin
68071-1808	GABAPENTIN	GABAPENTIN
68071-1907	GABAPENTIN	GABAPENTIN
68071-1995	Gabapentin	Gabapentin
68071-3230	GABAPENTIN	GABAPENTIN
68071-3046	Gabapentin	Gabapentin
68071-3244	Gabapentin	Gabapentin
68071-4087	Gabapentin	Gabapentin
68071-3086	GABAPENTIN	GABAPENTIN
68071-3383	GABAPENTIN	GABAPENTIN
68071-3314	GABAPENTIN	GABAPENTIN
68071-4049	GABAPENTIN	GABAPENTIN
68071-4241	GABAPENTIN	GABAPENTIN
68071-4099	Gabapentin	Gabapentin
68071-4113	Gabapentin	Gabapentin
68071-4292	Gabapentin	Gabapentin
68071-4180	Gabapentin	Gabapentin
68071-4090	Gabapentin	Gabapentin
68071-4329	Gabapentin	Gabapentin
68071-4603	Gabapentin	Gabapentin
68071-4169	Gabapentin	Gabapentin
68071-4346	Gabapentin	Gabapentin
68071-4366	Gabapentin	Gabapentin
68071-4729	Gabapentin	Gabapentin
68071-4402	GABAPENTIN	GABAPENTIN
68071-4784	GABAPENTIN	GABAPENTIN
68084-774	Gabapentin	Gabapentin
68084-783	Gabapentin	Gabapentin
68084-797	Gabapentin	Gabapentin
68084-762	Gabapentin	Gabapentin
0440-5562	GABAPENTIN	GABAPENTIN
0440-5563	GABAPENTIN	GABAPENTIN
68084-802	Gabapentin	Gabapentin
68151-1028	Gabapentin	Gabapentin