FDA.reportPublic FDA data

Pregabalin

Product NDC
80425-0327
11-digit product format
804250327
Labeler code
80425
Product ID
80425-0327_204992ef-3773-0e50-e063-6294a90a8b32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA208677
Marketing category
ANDA
Marketing start
2023-04-17
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
Rxcui483442, 483448

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
80425-0327-1Pregabalin30 in 1 BOTTLECAPSULE302
80425-0327-2Pregabalin60 in 1 BOTTLECAPSULE602
80425-0327-3Pregabalin90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0327-1EA - Each80425-0327dac06c44-4c26-4610-8f31-7d21dc6ae4cb12023-06-06
80425-0327-2EA - Each80425-0327851dd67a-3cd8-4420-bac8-07445d6e889312023-06-06
80425-0327-3EA - Each80425-03278a87f262-f5b1-48b6-b796-4331c47a3c8012023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0327PREGABALIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20240829_f98c5df7-9b85-eacc-e053-6294a90a88ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483442pregabalin 25 MG Oral CapsulePSNf98c5df7-9b85-eacc-e053-6294a90a88ec2
483448pregabalin 50 MG Oral CapsulePSNf98c5df7-9b85-eacc-e053-6294a90a88ec2
483442pregabalin 25 MG Oral CapsuleSCDf98c5df7-9b85-eacc-e053-6294a90a88ec2
483448pregabalin 50 MG Oral CapsuleSCDf98c5df7-9b85-eacc-e053-6294a90a88ec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0327-18042503270130 CAPSULE in 1 BOTTLE (80425-0327-1) 30 capsule2023-04-17NoNoHistorical
80425-0327-28042503270260 CAPSULE in 1 BOTTLE (80425-0327-2) 60 capsule2023-04-17NoNoHistorical
80425-0327-38042503270390 CAPSULE in 1 BOTTLE (80425-0327-3) 90 capsule2023-04-17NoNoHistorical