Pregabalin

Product NDC
63629-8196
11-digit product format
636298196
Labeler code
63629
Product ID
63629-8196_6152d517-2ff5-4109-96ce-69fc626ab5cb
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
75 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
PREGABALIN75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483450

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
63629-8196-1Pregabalin30 in 1 BOTTLECAPSULE30105
63629-8196-2Pregabalin60 in 1 BOTTLECAPSULE60105
63629-8196-3Pregabalin90 in 1 BOTTLECAPSULE90105
63629-8196-4Pregabalin120 in 1 BOTTLECAPSULE120105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8196-1EA - Each63629-819623596cd2-eaff-43cb-9596-0dce8f1de1ec12019-09-05
63629-8196-2EA - Each63629-81968d8b4f92-c58a-4570-b00e-1749fb41c87c12019-09-05
63629-8196-3EA - Each63629-81967b9d33e6-f54d-4022-9732-27192f7a6ffa12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8196PREGABALIN CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 4 package rows20240724_e1ed81bc-1597-4bc5-80cd-09977a154e4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483450pregabalin 75 MG Oral CapsulePSNe1ed81bc-1597-4bc5-80cd-09977a154e4b105
483450pregabalin 75 MG Oral CapsuleSCDe1ed81bc-1597-4bc5-80cd-09977a154e4b105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8196-16362981960130 CAPSULE in 1 BOTTLE (63629-8196-1) 30 capsule2019-08-010000-00-00NoNoCurrent
63629-8196-26362981960260 CAPSULE in 1 BOTTLE (63629-8196-2) 60 capsule2019-07-310000-00-00NoNoCurrent
63629-8196-36362981960390 CAPSULE in 1 BOTTLE (63629-8196-3) 90 capsule2019-07-250000-00-00NoNoCurrent
63629-8196-463629819604120 CAPSULE in 1 BOTTLE (63629-8196-4) 120 capsule2024-07-080000-00-00NoNoCurrent