FDA.reportPublic FDA data

PREGABALIN

Product NDC
71209-032
11-digit product format
712090032
Labeler code
71209
Product ID
71209-032_be6557c8-0d68-4313-a689-c2fdfb1d505e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA206452
Marketing category
ANDA
Marketing start
2023-07-13
Substance
PREGABALIN
Active strength
25 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PREGABALIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71209-032-04PREGABALIN90 in 1 BOTTLECAPSULE9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-032PREGABALIN CAPSULE [CADILA PHARMACEUTICALS LIMITED]10Current NDC, 1 package rows20240515_170c0c95-2ee8-4dff-bbd6-b87a21e8cf81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN170c0c95-2ee8-4dff-bbd6-b87a21e8cf8111
483440pregabalin 150 MG Oral CapsulePSN170c0c95-2ee8-4dff-bbd6-b87a21e8cf8111
483446pregabalin 200 MG Oral CapsulePSN170c0c95-2ee8-4dff-bbd6-b87a21e8cf8111
577127pregabalin 225 MG Oral CapsulePSN170c0c95-2ee8-4dff-bbd6-b87a21e8cf8111
483442pregabalin 25 MG Oral CapsulePSN170c0c95-2ee8-4dff-bbd6-b87a21e8cf8111
483444pregabalin 300 MG Oral CapsulePSN170c0c95-2ee8-4dff-bbd6-b87a21e8cf8111
483448pregabalin 50 MG Oral CapsulePSN170c0c95-2ee8-4dff-bbd6-b87a21e8cf8111
483450pregabalin 75 MG Oral CapsulePSN170c0c95-2ee8-4dff-bbd6-b87a21e8cf8111
483438pregabalin 100 MG Oral CapsuleSCD170c0c95-2ee8-4dff-bbd6-b87a21e8cf8111
483440pregabalin 150 MG Oral CapsuleSCD170c0c95-2ee8-4dff-bbd6-b87a21e8cf8111
483446pregabalin 200 MG Oral CapsuleSCD170c0c95-2ee8-4dff-bbd6-b87a21e8cf8111
577127pregabalin 225 MG Oral CapsuleSCD170c0c95-2ee8-4dff-bbd6-b87a21e8cf8111
483442pregabalin 25 MG Oral CapsuleSCD170c0c95-2ee8-4dff-bbd6-b87a21e8cf8111
483444pregabalin 300 MG Oral CapsuleSCD170c0c95-2ee8-4dff-bbd6-b87a21e8cf8111
483448pregabalin 50 MG Oral CapsuleSCD170c0c95-2ee8-4dff-bbd6-b87a21e8cf8111
483450pregabalin 75 MG Oral CapsuleSCD170c0c95-2ee8-4dff-bbd6-b87a21e8cf8111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71209-032-047120900320490 CAPSULE in 1 BOTTLE (71209-032-04) 90 capsule2023-07-13NoNoCurrent