Pregabalin

Product NDC: 70518-4585
11-digit product format: 705184585
Labeler code: 70518
Product ID: 70518-4585_4cec8699-7b8d-a64f-e063-6394a90ac5b4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pregabalin
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA206912
Marketing category: ANDA
Marketing start: 2026-03-13
Substance: PREGABALIN
Active strength: 50 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	50 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	55JG375S6M
Rxcui	483448

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
441d8579-bd15-4585-93f4-9de3db2d851d	Product name	4	20251114
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
70518-4585-0	Pregabalin	90 in 1 BOTTLE, PLASTIC	CAPSULE	90		1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
483448	pregabalin 50 MG Oral Capsule	PSN	c60752f8-20d5-4333-bf33-a656eab01d6b	1
483448	pregabalin 50 MG Oral Capsule	SCD	c60752f8-20d5-4333-bf33-a656eab01d6b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4585-0	70518458500	90 CAPSULE in 1 BOTTLE, PLASTIC (70518-4585-0)	90 capsule	2026-03-13	No	No	Historical