Pregabalin

Product NDC: 50090-5177
11-digit product format: 500905177
Labeler code: 50090
Product ID: 50090-5177_646e7032-ee3c-4d03-beb1-44153fa6e1d7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA211384
Marketing category: ANDA
Marketing start: 2019-07-19
Marketing end: 0000-00-00
Substance: PREGABALIN
Active strength: 75 mg/1
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
441d8579-bd15-4585-93f4-9de3db2d851d	Product name	4	20251114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
004d1029-ec13-fc89-74f4-3907cf5b6602	Product name	2	20140523

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5177-0	2023-01-30	C162847	48780-1	f386c64a-3dd8-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5177-0	Pregabalin	90 in 1 BOTTLE	CAPSULE	90		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5177	PREGABALIN CAPSULE [A-S MEDICATION SOLUTIONS]	1	Legacy NDC, 1 package rows	20201015_35814e1e-2eb0-4379-bd35-ce876b3476cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
483450	pregabalin 75 MG Oral Capsule	PSN	35814e1e-2eb0-4379-bd35-ce876b3476cd	1
483450	pregabalin 75 MG Oral Capsule	SCD	35814e1e-2eb0-4379-bd35-ce876b3476cd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5177-0	50090517700	90 CAPSULE in 1 BOTTLE (50090-5177-0)	90 capsule	2020-09-28	0000-00-00	No	No	Current