Pregabalin

Product NDC: 71205-621
11-digit product format: 712050621
Labeler code: 71205
Product ID: 71205-621_4702a3a6-2275-4978-83f9-1298d54ffa6a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pregabalin
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA207799
Marketing category: ANDA
Marketing start: 2019-07-21
Substance: PREGABALIN
Active strength: 75 mg/1
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Pregabalin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREGABALIN	75 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	55JG375S6M
Rxcui	483450

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
71205-621-30	Pregabalin	30 in 1 BOTTLE	CAPSULE	30		2
71205-621-60	Pregabalin	60 in 1 BOTTLE	CAPSULE	60		2
71205-621-90	Pregabalin	90 in 1 BOTTLE	CAPSULE	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-621-60	EA - Each	71205-621	b7b4fe98-4cb8-4e2d-b5a3-9ced0e1b12b6	1	2022-03-09
71205-621-90	EA - Each	71205-621	7de315ad-24db-49da-a9f1-2149d64db414	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-621	PREGABALIN CAPSULE [PROFICIENT RX LP]	2	Current NDC, Legacy NDC, 3 package rows	20220513_a1545bbb-b337-4760-ab4c-fb76ab019337.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
483450	pregabalin 75 MG Oral Capsule	PSN	a1545bbb-b337-4760-ab4c-fb76ab019337	2
483450	pregabalin 75 MG Oral Capsule	SCD	a1545bbb-b337-4760-ab4c-fb76ab019337	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-621-30	71205062130	30 CAPSULE in 1 BOTTLE (71205-621-30)	30 capsule	2021-11-17	0000-00-00	No	No	Current
71205-621-60	71205062160	60 CAPSULE in 1 BOTTLE (71205-621-60)	60 capsule	2021-11-17	0000-00-00	No	No	Current
71205-621-90	71205062190	90 CAPSULE in 1 BOTTLE (71205-621-90)	90 capsule	2021-11-17	0000-00-00	No	No	Current