Pregabalin

Product NDC: 67046-1628
11-digit product format: 670461628
Labeler code: 67046
Product ID: 67046-1628_486f605f-c7f0-6140-e063-6394a90ab77f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pregabalin
Dosage form: CAPSULE
Route: ORAL
Labeler: Coupler LLC
Application: ANDA205321
Marketing category: ANDA
Marketing start: 2025-12-18
Substance: PREGABALIN
Active strength: 100 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	100 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	55JG375S6M
Rxcui	483438

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
67046-1628-3	Pregabalin	30 in 1 BLISTER PACK	CAPSULE	30		2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
483438	pregabalin 100 MG Oral Capsule	PSN	463d31dd-ff14-cc89-e063-6294a90a2ea9	2
483438	pregabalin 100 MG Oral Capsule	SCD	463d31dd-ff14-cc89-e063-6294a90a2ea9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-1628-3	67046162803	30 CAPSULE in 1 BLISTER PACK (67046-1628-3)	30 capsule	2025-12-18	No	No	Historical