FDA.reportPublic FDA data

Pregabalin

Product NDC
63629-8248
11-digit product format
636298248
Labeler code
63629
Product ID
63629-8248_35a6ad33-9874-4be7-9396-7fdb0863ef86
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
300 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
PREGABALIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483444

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
63629-8248-1Pregabalin60 in 1 BOTTLECAPSULE60106
63629-8248-2Pregabalin90 in 1 BOTTLECAPSULE90106
63629-8248-3Pregabalin30 in 1 BOTTLECAPSULE30106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8248-2EA - Each63629-824874316ac3-5568-402c-8844-3c68cae16fe612020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8248PREGABALIN CAPSULE [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 3 package rows20250224_59f94cd9-0fc9-4e55-8004-578971a1b42f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483444pregabalin 300 MG Oral CapsulePSN59f94cd9-0fc9-4e55-8004-578971a1b42f106
483444pregabalin 300 MG Oral CapsuleSCD59f94cd9-0fc9-4e55-8004-578971a1b42f106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8248-16362982480160 CAPSULE in 1 BOTTLE (63629-8248-1) 60 capsule2019-09-240000-00-00NoNoCurrent
63629-8248-26362982480290 CAPSULE in 1 BOTTLE (63629-8248-2) 90 capsule2019-10-100000-00-00NoNoCurrent
63629-8248-36362982480330 CAPSULE in 1 BOTTLE (63629-8248-3) 30 capsule2022-06-300000-00-00NoNoCurrent