FDA.reportPublic FDA data

Pregabalin

Product NDC
80425-0025
11-digit product format
804250025
Labeler code
80425
Product ID
80425-0025_2a988314-6237-2d61-e063-6294a90a3e84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA209743
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
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
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
80425-0025-1Pregabalin60 in 1 BOTTLECAPSULE6011
80425-0025-2Pregabalin90 in 1 BOTTLECAPSULE9011
80425-0025-3Pregabalin30 in 1 BOTTLECAPSULE3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0025-1EA - Each80425-00255506d3d4-996b-4e04-9cdf-b8e2a077255912023-04-07
80425-0025-2EA - Each80425-00255e696cd1-45b4-4559-8639-099ea29557dd12023-04-07
80425-0025-3EA - Each80425-00257ff2d622-1c1b-45dc-a336-d7fb68c1a8a912023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0025PREGABALIN CAPSULE [ADVANCED RX OF TENNESSEE, LLC]11Current NDC, Legacy NDC, 3 package rows20250101_af739a0d-a3cd-754f-e053-2a95a90ad655.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483448pregabalin 50 MG Oral CapsulePSNaf739a0d-a3cd-754f-e053-2a95a90ad65511
483448pregabalin 50 MG Oral CapsuleSCDaf739a0d-a3cd-754f-e053-2a95a90ad65511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0025-18042500250160 CAPSULE in 1 BOTTLE (80425-0025-1) 60 capsule2019-07-190000-00-00NoNoCurrent
80425-0025-28042500250290 CAPSULE in 1 BOTTLE (80425-0025-2) 90 capsule2019-07-190000-00-00NoNoCurrent
80425-0025-38042500250330 CAPSULE in 1 BOTTLE (80425-0025-3) 30 capsule2019-07-190000-00-00NoNoCurrent