FDA.reportPublic FDA data

Pregabalin

Product NDC
80425-0397
11-digit product format
804250397
Labeler code
80425
Product ID
80425-0397_1a280b06-dc3b-3735-e063-6394a90ab02b
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
2024-06-04
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, 577127

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0397-1Pregabalin30 in 1 BOTTLECAPSULE302
80425-0397-2Pregabalin60 in 1 BOTTLECAPSULE602
80425-0397-3Pregabalin90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0397-1EA - Each80425-03973c72220d-e85e-4787-a30e-d5eb63357c0612024-07-12
80425-0397-2EA - Each80425-03973fcf1d01-f037-44e6-aa3b-68cb8058e64412024-07-12
80425-0397-3EA - Each80425-0397952f1e6a-ae82-4b78-a129-af4fcc77997912024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0397PREGABALIN CAPSULE [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 3 package rows20240606_1a15cd11-0db9-2bc8-e063-6394a90a11fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483440pregabalin 150 MG Oral CapsulePSN1a15cd11-0db9-2bc8-e063-6394a90a11fb2
577127pregabalin 225 MG Oral CapsulePSN1a15cd11-0db9-2bc8-e063-6394a90a11fb2
483440pregabalin 150 MG Oral CapsuleSCD1a15cd11-0db9-2bc8-e063-6394a90a11fb2
577127pregabalin 225 MG Oral CapsuleSCD1a15cd11-0db9-2bc8-e063-6394a90a11fb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0397-18042503970130 CAPSULE in 1 BOTTLE (80425-0397-1) 30 capsule2024-06-04NoNoHistorical
80425-0397-28042503970260 CAPSULE in 1 BOTTLE (80425-0397-2) 60 capsule2024-06-04NoNoHistorical
80425-0397-38042503970390 CAPSULE in 1 BOTTLE (80425-0397-3) 90 capsule2024-06-04NoNoHistorical