Pregabalin

Product NDC
71610-926
11-digit product format
716100926
Labeler code
71610
Product ID
71610-926_3a136ad0-72ea-ec70-e063-6394a90a5cdc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA208677
Marketing category
ANDA
Marketing start
2021-08-24
Substance
PREGABALIN
Active strength
200 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
55JG375S6MPREGABALIN148553-50-8PREGABALIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-926-307161009263030 CAPSULE in 1 BOTTLE (71610-926-30) 30 capsule2025-07-16NoNoHistorical
71610-926-467161009264656 CAPSULE in 1 BOTTLE (71610-926-46) 56 capsule2025-07-16NoNoHistorical
71610-926-537161009265360 CAPSULE in 1 BOTTLE (71610-926-53) 60 capsule2025-07-16NoNoHistorical
71610-926-607161009266090 CAPSULE in 1 BOTTLE (71610-926-60) 90 capsule2025-07-16NoNoHistorical
71610-926-8071610092680180 CAPSULE in 1 BOTTLE (71610-926-80) 180 capsule2025-07-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PregabalinAphena Pharma Solutions - Tennessee, LLC2025-07-16HUMAN PRESCRIPTION DRUG LABEL1