FDA.reportPublic FDA data

Pregabalin

Product NDC
63629-8195
11-digit product format
636298195
Labeler code
63629
Product ID
63629-8195_55a06abd-87cd-4fa6-86f8-4e383718c695
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
50 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
PREGABALIN50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483448

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
63629-8195-1Pregabalin30 in 1 BOTTLECAPSULE3023
63629-8195-2Pregabalin60 in 1 BOTTLECAPSULE6023
63629-8195-3Pregabalin90 in 1 BOTTLECAPSULE9023
63629-8195-4Pregabalin15 in 1 BOTTLECAPSULE1523

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8195-1EA - Each63629-8195a8529f2d-839d-44ea-a394-e952ce7802f212019-09-05
63629-8195-2EA - Each63629-819567ccf03c-0540-4de1-87d0-dd839cd7cc9912019-09-05
63629-8195-3EA - Each63629-819533245ec9-b85f-4194-be78-a83c35fc0ad112019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8195PREGABALIN CAPSULE [BRYANT RANCH PREPACK]22Current NDC, Legacy NDC, 4 package rows20240724_247aedca-ae27-44c6-b32c-c95d26454566.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483448pregabalin 50 MG Oral CapsulePSN247aedca-ae27-44c6-b32c-c95d2645456623
483448pregabalin 50 MG Oral CapsuleSCD247aedca-ae27-44c6-b32c-c95d2645456623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8195-16362981950130 CAPSULE in 1 BOTTLE (63629-8195-1) 30 capsule2019-08-020000-00-00NoNoCurrent
63629-8195-26362981950260 CAPSULE in 1 BOTTLE (63629-8195-2) 60 capsule2019-07-310000-00-00NoNoCurrent
63629-8195-36362981950390 CAPSULE in 1 BOTTLE (63629-8195-3) 90 capsule2019-07-250000-00-00NoNoCurrent
63629-8195-46362981950415 CAPSULE in 1 BOTTLE (63629-8195-4) 15 capsule2024-07-08NoNoHistorical