PREGABALIN

Product NDC: 70518-4569
11-digit product format: 705184569
Labeler code: 70518
Product ID: 70518-4569_4a63fb61-2196-524c-e063-6294a90a9683
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA210432
Marketing category: ANDA
Marketing start: 2026-02-08
Substance: PREGABALIN
Active strength: 225 mg/1
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: PREGABALIN
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREGABALIN	225 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	55JG375S6M
Rxcui	577127

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
441d8579-bd15-4585-93f4-9de3db2d851d	Product name	4	20251114
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
004d1029-ec13-fc89-74f4-3907cf5b6602	Product name	2	20140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-4569-0	PREGABALIN	90 in 1 BOTTLE, PLASTIC	CAPSULE	90		1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
577127	pregabalin 225 MG Oral Capsule	PSN	1a8f13f6-0f4c-4194-ba37-b2d1a8fc4993	1
577127	pregabalin 225 MG Oral Capsule	SCD	1a8f13f6-0f4c-4194-ba37-b2d1a8fc4993	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4569-0	70518456900	90 CAPSULE in 1 BOTTLE, PLASTIC (70518-4569-0)	90 capsule	2026-02-08	No	No	Historical