FDA.reportPublic FDA data

Pregabalin

Product NDC
80425-0178
11-digit product format
804250178
Labeler code
80425
Product ID
80425-0178_2a99a670-af33-299d-e063-6294a90a05d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA206912
Marketing category
ANDA
Marketing start
2019-10-08
Substance
PREGABALIN
Active strength
150 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
PREGABALIN150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483440

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
80425-0178-1Pregabalin60 in 1 BOTTLECAPSULE605
80425-0178-2Pregabalin90 in 1 BOTTLECAPSULE905
80425-0178-3Pregabalin30 in 1 BOTTLECAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0178-1EA - Each80425-0178b0e689a2-601f-4330-b286-5236f0230e1b12023-04-07
80425-0178-2EA - Each80425-0178d9266e5e-3e04-41d1-9843-1f85e80407db12023-04-07
80425-0178-3EA - Each80425-0178f94bf7dc-0a1c-498e-8fe4-f3c093c1120812023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0178PREGABALIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 3 package rows20250101_d28168cd-9b7a-f8df-e053-2995a90ad97f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483440pregabalin 150 MG Oral CapsulePSNd28168cd-9b7a-f8df-e053-2995a90ad97f5
483440pregabalin 150 MG Oral CapsuleSCDd28168cd-9b7a-f8df-e053-2995a90ad97f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0178-18042501780160 CAPSULE in 1 BOTTLE (80425-0178-1) 60 capsule2019-10-080000-00-00NoNoCurrent
80425-0178-28042501780290 CAPSULE in 1 BOTTLE (80425-0178-2) 90 capsule2019-10-080000-00-00NoNoCurrent
80425-0178-38042501780330 CAPSULE in 1 BOTTLE (80425-0178-3) 30 capsule2023-03-30NoNoCurrent