FDA.reportPublic FDA data

Pregabalin

Product NDC
80425-0433
11-digit product format
804250433
Labeler code
80425
Product ID
80425-0433_204992ef-3773-0e50-e063-6294a90a8b32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA208677
Marketing category
ANDA
Marketing start
2024-08-22
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
Rxcui483442, 483448

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
80425-0433-1Pregabalin30 in 1 BOTTLECAPSULE302
80425-0433-2Pregabalin60 in 1 BOTTLECAPSULE602
80425-0433-3Pregabalin90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0433-1EA - Each80425-0433c41b0fbd-8f97-4337-b82f-8f1010a54a6112024-10-04
80425-0433-2EA - Each80425-043361346df3-a5a2-48ea-8674-bfa13526af0912024-10-04
80425-0433-3EA - Each80425-04337e05d1bf-209a-4f93-b700-207c60c14ebe12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0433PREGABALIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20240829_f98c5df7-9b85-eacc-e053-6294a90a88ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483442pregabalin 25 MG Oral CapsulePSNf98c5df7-9b85-eacc-e053-6294a90a88ec2
483448pregabalin 50 MG Oral CapsulePSNf98c5df7-9b85-eacc-e053-6294a90a88ec2
483442pregabalin 25 MG Oral CapsuleSCDf98c5df7-9b85-eacc-e053-6294a90a88ec2
483448pregabalin 50 MG Oral CapsuleSCDf98c5df7-9b85-eacc-e053-6294a90a88ec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0433-18042504330130 CAPSULE in 1 BOTTLE (80425-0433-1) 30 capsule2024-08-22NoNoHistorical
80425-0433-28042504330260 CAPSULE in 1 BOTTLE (80425-0433-2) 60 capsule2024-08-22NoNoHistorical
80425-0433-38042504330390 CAPSULE in 1 BOTTLE (80425-0433-3) 90 capsule2024-08-22NoNoHistorical