FDA.reportPublic FDA data

Pregabalin

Product NDC
80425-0029
11-digit product format
804250029
Labeler code
80425
Product ID
80425-0029_2a984dd9-7294-77f0-e063-6294a90a8f1e
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
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
80425-0029-1Pregabalin60 in 1 BOTTLECAPSULE607
80425-0029-2Pregabalin90 in 1 BOTTLECAPSULE907
80425-0029-3Pregabalin30 in 1 BOTTLECAPSULE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0029-1EA - Each80425-00290511c5d5-7ea6-4a47-8714-e802f6cb8c7012023-04-07
80425-0029-2EA - Each80425-0029b4269445-5768-4e24-974e-62210b5bfebc12023-04-07
80425-0029-3EA - Each80425-00293d5cd76c-f0f1-4d7a-bb72-89f4ad3b073612023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0029PREGABALIN CAPSULE [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_afc89ca3-5597-1c75-e053-2a95a90a3ff2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483450pregabalin 75 MG Oral CapsulePSNafc89ca3-5597-1c75-e053-2a95a90a3ff27
483450pregabalin 75 MG Oral CapsuleSCDafc89ca3-5597-1c75-e053-2a95a90a3ff27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0029-18042500290160 CAPSULE in 1 BOTTLE (80425-0029-1) 60 capsule2019-07-190000-00-00NoNoCurrent
80425-0029-28042500290290 CAPSULE in 1 BOTTLE (80425-0029-2) 90 capsule2019-07-190000-00-00NoNoCurrent
80425-0029-38042500290330 CAPSULE in 1 BOTTLE (80425-0029-3) 30 capsule2019-07-19NoNoHistorical