FDA.reportPublic FDA data

Pregabalin

Product NDC
71610-319
11-digit product format
716100319
Labeler code
71610
Product ID
71610-319_9d6ac8b5-77e4-4c4f-9c24-8d3043149146
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA211384
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
225 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
PREGABALIN225 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127

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
71610-319-46Pregabalin56 in 1 BOTTLECAPSULE5611
71610-319-53Pregabalin60 in 1 BOTTLECAPSULE6011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-319PREGABALIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]8Current NDC, Legacy NDC, 2 package rows20240305_bf710bcf-75ed-4184-b9c3-81cd05a780a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483440pregabalin 150 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483446pregabalin 200 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
577127pregabalin 225 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483442pregabalin 25 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483444pregabalin 300 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483448pregabalin 50 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483450pregabalin 75 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483438pregabalin 100 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483440pregabalin 150 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483446pregabalin 200 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
577127pregabalin 225 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483442pregabalin 25 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483444pregabalin 300 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483448pregabalin 50 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483450pregabalin 75 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-319-467161003194656 CAPSULE in 1 BOTTLE (71610-319-46) 56 capsule2024-01-10NoNoCurrent
71610-319-537161003195360 CAPSULE in 1 BOTTLE (71610-319-53) 60 capsule2019-08-120000-00-00NoNoCurrent