FDA.reportPublic FDA data

Pregabalin

Product NDC
63629-8197
11-digit product format
636298197
Labeler code
63629
Product ID
63629-8197_e388e363-0fd6-4103-b87a-a5f018c7d299
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
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
63629-8197-1Pregabalin30 in 1 BOTTLECAPSULE30105
63629-8197-2Pregabalin90 in 1 BOTTLECAPSULE90105
63629-8197-3Pregabalin60 in 1 BOTTLECAPSULE60105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8197-1EA - Each63629-8197d5586eca-f2fd-4368-8f12-eeac11843bfb12019-09-05
63629-8197-2EA - Each63629-8197adf91b28-7f4d-4e29-82c2-c11a4d2a723012019-09-05
63629-8197-3EA - Each63629-81971514634d-6ae6-4b75-8910-2b0a6c06e1d912019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8197PREGABALIN CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 3 package rows20240724_fd568ede-dac7-4910-bb18-65fb00f2636e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSNfd568ede-dac7-4910-bb18-65fb00f2636e105
483438pregabalin 100 MG Oral CapsuleSCDfd568ede-dac7-4910-bb18-65fb00f2636e105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8197-16362981970130 CAPSULE in 1 BOTTLE (63629-8197-1) 30 capsule2019-08-010000-00-00NoNoCurrent
63629-8197-26362981970290 CAPSULE in 1 BOTTLE (63629-8197-2) 90 capsule2019-07-250000-00-00NoNoCurrent
63629-8197-36362981970360 CAPSULE in 1 BOTTLE (63629-8197-3) 60 capsule2019-08-010000-00-00NoNoCurrent