FDA.reportPublic FDA data

Pregabalin

Product NDC
63629-8239
11-digit product format
636298239
Labeler code
63629
Product ID
63629-8239_2d543493-c850-418a-b922-419026ac2441
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
225 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
PREGABALIN225 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui577127

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
63629-8239-1Pregabalin30 in 1 BOTTLECAPSULE30105
63629-8239-2Pregabalin60 in 1 BOTTLECAPSULE60105
63629-8239-3Pregabalin90 in 1 BOTTLECAPSULE90105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8239-3EA - Each63629-82392bb62425-d6e6-4f26-a21e-de3d152c863f12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8239PREGABALIN CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 3 package rows20240724_d70a5102-eb8d-45f1-acd0-692e9208428e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577127pregabalin 225 MG Oral CapsulePSNd70a5102-eb8d-45f1-acd0-692e9208428e105
577127pregabalin 225 MG Oral CapsuleSCDd70a5102-eb8d-45f1-acd0-692e9208428e105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8239-16362982390130 CAPSULE in 1 BOTTLE (63629-8239-1) 30 capsule2022-06-300000-00-00NoNoCurrent
63629-8239-26362982390260 CAPSULE in 1 BOTTLE (63629-8239-2) 60 capsule2019-09-060000-00-00NoNoCurrent
63629-8239-36362982390390 CAPSULE in 1 BOTTLE (63629-8239-3) 90 capsule2019-09-060000-00-00NoNoCurrent