Gabapentin

Product NDC: 71610-767
11-digit product format: 716100767
Labeler code: 71610
Product ID: 71610-767_12caf943-5e83-4185-8d53-4b537f26087c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA205101
Marketing category: ANDA
Marketing start: 2016-02-04
Substance: GABAPENTIN
Active strength: 600 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Related Records

UNII	Preferred term	Registry number	Matched term
6CW7F3G59X	GABAPENTIN	60142-96-3	GABAPENTIN

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71610-767-30	71610076730	30 TABLET in 1 BOTTLE (71610-767-30)	30 tablet	2024-01-09	No	No	Historical
71610-767-45	71610076745	45 TABLET in 1 BOTTLE (71610-767-45)	45 tablet	2024-01-09	No	No	Historical
71610-767-53	71610076753	60 TABLET in 1 BOTTLE (71610-767-53)	60 tablet	2024-01-09	No	No	Historical
71610-767-60	71610076760	90 TABLET in 1 BOTTLE (71610-767-60)	90 tablet	2024-01-09	No	No	Historical
71610-767-70	71610076770	120 TABLET in 1 BOTTLE (71610-767-70)	120 tablet	2024-01-09	No	No	Historical
71610-767-73	71610076773	135 TABLET in 1 BOTTLE (71610-767-73)	135 tablet	2024-01-09	No	No	Historical
71610-767-80	71610076780	180 TABLET in 1 BOTTLE (71610-767-80)	180 tablet	2024-01-09	No	No	Historical
71610-767-92	71610076792	270 TABLET in 1 BOTTLE (71610-767-92)	270 tablet	2024-01-09	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Gabapentin	Aphena Pharma Solutions - Tennessee, LLC	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	1