FDA.reportPublic FDA data

Pregabalin

Product NDC
63629-8198
11-digit product format
636298198
Labeler code
63629
Product ID
63629-8198_1021e335-13e5-4a79-b32b-d691bb3f3881
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
150 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
PREGABALIN150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483440

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
63629-8198-1Pregabalin30 in 1 BOTTLECAPSULE30105
63629-8198-2Pregabalin60 in 1 BOTTLECAPSULE60105
63629-8198-3Pregabalin90 in 1 BOTTLECAPSULE90105
63629-8198-4Pregabalin180 in 1 BOTTLECAPSULE180105
63629-8198-5Pregabalin120 in 1 BOTTLECAPSULE120105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8198-1EA - Each63629-8198cf9f08b7-4409-4563-b28e-0e0e4c86ca5c12019-11-12
63629-8198-2EA - Each63629-8198bfb65fc7-3b29-4fb3-a82f-64a5a2c7ad6d12019-09-05
63629-8198-3EA - Each63629-8198b123eb8c-8029-4d29-8a3c-372d35bb3e6312019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8198PREGABALIN CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 5 package rows20240724_8a7acea4-108d-40d2-a2a7-36088be97248.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483440pregabalin 150 MG Oral CapsulePSN8a7acea4-108d-40d2-a2a7-36088be97248105
483440pregabalin 150 MG Oral CapsuleSCD8a7acea4-108d-40d2-a2a7-36088be97248105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8198-16362981980130 CAPSULE in 1 BOTTLE (63629-8198-1) 30 capsule2019-10-040000-00-00NoNoCurrent
63629-8198-26362981980260 CAPSULE in 1 BOTTLE (63629-8198-2) 60 capsule2019-07-310000-00-00NoNoCurrent
63629-8198-36362981980390 CAPSULE in 1 BOTTLE (63629-8198-3) 90 capsule2019-07-250000-00-00NoNoCurrent
63629-8198-463629819804180 CAPSULE in 1 BOTTLE (63629-8198-4) 180 capsule2019-07-250000-00-00NoNoCurrent
63629-8198-563629819805120 CAPSULE in 1 BOTTLE (63629-8198-5) 120 capsule2024-07-08NoNoHistorical