Gabapentin

Product NDC: 55700-949
11-digit product format: 557000949
Labeler code: 55700
Product ID: 55700-949_a1d85d35-87be-497d-acf2-5f9ef9267328
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA204989
Marketing category: ANDA
Marketing start: 2021-12-07
Marketing end: 2027-05-31
Substance: GABAPENTIN
Active strength: 300 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Current FDA listing: Yes

openFDA Listing Details

Product ID: 55700-949_a1d85d35-87be-497d-acf2-5f9ef9267328
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Gabapentin
Generic name: Gabapentin
Dosage form: CAPSULE
Route: ORAL
Marketing start: 2021-12-07
Marketing end: 2027-05-31
Marketing category: ANDA
Application number: ANDA204989
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]

Ingredient	Strength
GABAPENTIN	300 mg/1

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

Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-949-01	55700094901	120 CAPSULE in 1 BOTTLE, PLASTIC (55700-949-01)	120 capsule	2021-12-07	2027-05-31	No	No	Current
55700-949-30	55700094930	30 CAPSULE in 1 BOTTLE, PLASTIC (55700-949-30)	30 capsule	2021-12-07	0000-00-00	No	No	Current
55700-949-60	55700094960	60 CAPSULE in 1 BOTTLE, PLASTIC (55700-949-60)	60 capsule	2021-12-07	2027-05-31	No	No	Current
55700-949-90	55700094990	90 CAPSULE in 1 BOTTLE, PLASTIC (55700-949-90)	90 capsule	2021-12-07	2027-05-31	No	No	Current

Title	Manufacturer	Effective date	Type	Version
Gabapentin	Quality Care Products, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	6