FDA.reportPublic FDA data

Pregabalin

Product NDC
63629-8208
11-digit product format
636298208
Labeler code
63629
Product ID
63629-8208_1db95739-6c68-4251-bd34-ed1e52b26940
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
200 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
PREGABALIN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483446

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
63629-8208-1Pregabalin30 in 1 BOTTLECAPSULE30105
63629-8208-2Pregabalin60 in 1 BOTTLECAPSULE60105
63629-8208-3Pregabalin90 in 1 BOTTLECAPSULE90105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8208-1EA - Each63629-8208f5799e0f-fbae-470a-9a12-b86b596312a912019-09-05
63629-8208-2EA - Each63629-82086400c792-ae04-41f7-adea-947e2c541e8612019-09-05
63629-8208-3EA - Each63629-82085e317e5b-85b6-4f01-adf6-f37f50a1388a12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8208PREGABALIN CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 3 package rows20240724_2ceccc4d-97e2-4eb0-841f-23609187710c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483446pregabalin 200 MG Oral CapsulePSN2ceccc4d-97e2-4eb0-841f-23609187710c105
483446pregabalin 200 MG Oral CapsuleSCD2ceccc4d-97e2-4eb0-841f-23609187710c105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8208-16362982080130 CAPSULE in 1 BOTTLE (63629-8208-1) 30 capsule2019-08-010000-00-00NoNoCurrent
63629-8208-26362982080260 CAPSULE in 1 BOTTLE (63629-8208-2) 60 capsule2019-08-010000-00-00NoNoCurrent
63629-8208-36362982080390 CAPSULE in 1 BOTTLE (63629-8208-3) 90 capsule2019-08-090000-00-00NoNoCurrent