FDA.reportPublic FDA data

Pregabalin

Product NDC
80425-0028
11-digit product format
804250028
Labeler code
80425
Product ID
80425-0028_2a987953-08d0-1c4c-e063-6394a90a5a82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA208677
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
75 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
PREGABALIN75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483450

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
80425-0028-1Pregabalin60 in 1 BOTTLECAPSULE608
80425-0028-2Pregabalin90 in 1 BOTTLECAPSULE908
80425-0028-3Pregabalin30 in 1 BOTTLECAPSULE308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0028-1EA - Each80425-0028fd103574-1296-418b-b410-862560a6174812023-04-07
80425-0028-2EA - Each80425-00285845667a-2eaa-45ac-9c00-e77b5f9ec66512023-04-07
80425-0028-3EA - Each80425-002869a83254-2c86-40f3-880a-ecb7ead0991712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0028PREGABALIN CAPSULE [ADVANCED RX OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 3 package rows20250101_afc8c76e-9b21-7ddb-e053-2a95a90ad736.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483450pregabalin 75 MG Oral CapsulePSNafc8c76e-9b21-7ddb-e053-2a95a90ad7368
483450pregabalin 75 MG Oral CapsuleSCDafc8c76e-9b21-7ddb-e053-2a95a90ad7368

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0028-18042500280160 CAPSULE in 1 BOTTLE (80425-0028-1) 60 capsule2019-07-190000-00-00NoNoCurrent
80425-0028-28042500280290 CAPSULE in 1 BOTTLE (80425-0028-2) 90 capsule2019-07-190000-00-00NoNoCurrent
80425-0028-38042500280330 CAPSULE in 1 BOTTLE (80425-0028-3) 30 capsule2023-04-04NoNoHistorical