Pregabalin

Product NDC
71335-2343
11-digit product format
713352343
Labeler code
71335
Product ID
71335-2343_2fa60c70-2012-44d1-b406-38b9bb5156b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208677
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
100 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
IngredientStrength
PREGABALIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483438

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2343-1Pregabalin30 in 1 BOTTLECAPSULE30103
71335-2343-2Pregabalin90 in 1 BOTTLECAPSULE90103
71335-2343-3Pregabalin60 in 1 BOTTLECAPSULE60103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2343PREGABALIN CAPSULE [BRYANT RANCH PREPACK]103Current NDC, 3 package rows20250409_29a869b8-0d9f-4e3f-820a-061aa42ee482.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN29a869b8-0d9f-4e3f-820a-061aa42ee482103
483438pregabalin 100 MG Oral CapsuleSCD29a869b8-0d9f-4e3f-820a-061aa42ee482103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2343-17133523430130 CAPSULE in 1 BOTTLE (71335-2343-1) 30 capsule2024-07-16NoNoHistorical
71335-2343-27133523430290 CAPSULE in 1 BOTTLE (71335-2343-2) 90 capsule2024-07-16NoNoHistorical
71335-2343-37133523430360 CAPSULE in 1 BOTTLE (71335-2343-3) 60 capsule2024-07-16NoNoHistorical