FDA.reportPublic FDA data

Pregabalin

Product NDC
82804-184
11-digit product format
828040184
Labeler code
82804
Product ID
82804-184_2b87989d-6411-4996-8f05-05806ab80525
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA206912
Marketing category
ANDA
Marketing start
2019-10-08
Substance
PREGABALIN
Active strength
50 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
PREGABALIN50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483448

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-184-30Pregabalin30 in 1 BOTTLECAPSULE301
82804-184-60Pregabalin60 in 1 BOTTLECAPSULE601
82804-184-90Pregabalin90 in 1 BOTTLECAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-184PREGABALIN CAPSULE [PROFICIENT RX LP]1Current NDC, 3 package rows20250119_2b87989d-6411-4996-8f05-05806ab80525.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483448pregabalin 50 MG Oral CapsulePSN2b87989d-6411-4996-8f05-05806ab805251
483448pregabalin 50 MG Oral CapsuleSCD2b87989d-6411-4996-8f05-05806ab805251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-184-308280401843030 CAPSULE in 1 BOTTLE (82804-184-30) 30 capsule2025-01-02NoNoCurrent
82804-184-608280401846060 CAPSULE in 1 BOTTLE (82804-184-60) 60 capsule2025-01-02NoNoCurrent
82804-184-908280401849090 CAPSULE in 1 BOTTLE (82804-184-90) 90 capsule2025-01-02NoNoCurrent