FDA.reportPublic FDA data

Pregabalin

Product NDC
82804-274
11-digit product format
828040274
Labeler code
82804
Product ID
82804-274_323587d5-4fdd-4a3c-9291-77c009fb6fb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208677
Marketing category
ANDA
Marketing start
2021-08-24
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
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
82804-274-60Pregabalin60 in 1 BOTTLECAPSULE602
82804-274-90Pregabalin90 in 1 BOTTLECAPSULE902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN32789571-a566-46fa-ba41-bd3c86276ecf2
483438pregabalin 100 MG Oral CapsuleSCD32789571-a566-46fa-ba41-bd3c86276ecf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-274-608280402746060 CAPSULE in 1 BOTTLE (82804-274-60) 60 capsule2026-03-27NoNoCurrent
82804-274-908280402749090 CAPSULE in 1 BOTTLE (82804-274-90) 90 capsule2026-04-29NoNoCurrent