FDA.reportPublic FDA data

PREGABALIN

Product NDC
80425-0185
11-digit product format
804250185
Labeler code
80425
Product ID
80425-0185_27606bf8-5738-d374-e063-6394a90a10f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA207799
Marketing category
ANDA
Marketing start
2019-07-21
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, 483448, 483450

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
80425-0185-1PREGABALIN30 in 1 BOTTLECAPSULE307
80425-0185-2PREGABALIN60 in 1 BOTTLECAPSULE607
80425-0185-3PREGABALIN90 in 1 BOTTLECAPSULE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0185-1EA - Each80425-01853270f391-a2ec-4234-98e0-d8c13c5e22b212023-06-06
80425-0185-2EA - Each80425-01855620b3dd-776c-4ee1-92f2-73b7f26c6d9112023-04-07
80425-0185-3EA - Each80425-0185834c3e53-a203-4dd9-898a-20b7bd89e8bd12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0185PREGABALIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20241123_d2813712-d7f6-6144-e053-2995a90a3c5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483440pregabalin 150 MG Oral CapsulePSNd2813712-d7f6-6144-e053-2995a90a3c5d7
483448pregabalin 50 MG Oral CapsulePSNd2813712-d7f6-6144-e053-2995a90a3c5d7
483450pregabalin 75 MG Oral CapsulePSNd2813712-d7f6-6144-e053-2995a90a3c5d7
483440pregabalin 150 MG Oral CapsuleSCDd2813712-d7f6-6144-e053-2995a90a3c5d7
483448pregabalin 50 MG Oral CapsuleSCDd2813712-d7f6-6144-e053-2995a90a3c5d7
483450pregabalin 75 MG Oral CapsuleSCDd2813712-d7f6-6144-e053-2995a90a3c5d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0185-18042501850130 CAPSULE in 1 BOTTLE (80425-0185-1) 30 capsule2023-05-17NoNoCurrent
80425-0185-28042501850260 CAPSULE in 1 BOTTLE (80425-0185-2) 60 capsule2019-07-210000-00-00NoNoCurrent
80425-0185-38042501850390 CAPSULE in 1 BOTTLE (80425-0185-3) 90 capsule2019-07-210000-00-00NoNoCurrent