FDA.reportPublic FDA data

Pregabalin

Product NDC
80425-0152
11-digit product format
804250152
Labeler code
80425
Product ID
80425-0152_2a99b1dd-becd-79f9-e063-6394a90a35f3
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
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
80425-0152-1Pregabalin30 in 1 BOTTLECAPSULE307
80425-0152-2Pregabalin60 in 1 BOTTLECAPSULE607
80425-0152-3Pregabalin90 in 1 BOTTLECAPSULE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0152-1EA - Each80425-015273fb64d6-4ab3-4950-abc6-83dc9526c25512023-04-07
80425-0152-2EA - Each80425-0152dcdaf124-5c62-4490-8bc0-56dd8ba5f9bd12023-06-06
80425-0152-3EA - Each80425-0152dc199216-45d0-4937-9869-cf41aed4332112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0152PREGABALIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_c8acdbcf-3076-63b2-e053-2a95a90aa3c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483448pregabalin 50 MG Oral CapsulePSNc8acdbcf-3076-63b2-e053-2a95a90aa3c47
483448pregabalin 50 MG Oral CapsuleSCDc8acdbcf-3076-63b2-e053-2a95a90aa3c47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0152-18042501520130 CAPSULE in 1 BOTTLE (80425-0152-1) 30 capsule2019-10-080000-00-00NoNoCurrent
80425-0152-28042501520260 CAPSULE in 1 BOTTLE (80425-0152-2) 60 capsule2019-10-080000-00-00NoNoCurrent
80425-0152-38042501520390 CAPSULE in 1 BOTTLE (80425-0152-3) 90 capsule2019-10-080000-00-00NoNoCurrent