FDA.reportPublic FDA data

Pregabalin

Product NDC
71610-931
11-digit product format
716100931
Labeler code
71610
Product ID
71610-931_3ab57054-02c3-5e28-e063-6294a90a71ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA208677
Marketing category
ANDA
Marketing start
2021-08-24
Substance
PREGABALIN
Active strength
25 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
PREGABALIN25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483442

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
71610-931-30Pregabalin30 in 1 BOTTLECAPSULE301
71610-931-46Pregabalin56 in 1 BOTTLECAPSULE561
71610-931-53Pregabalin60 in 1 BOTTLECAPSULE601
71610-931-54Pregabalin84 in 1 BOTTLECAPSULE841
71610-931-60Pregabalin90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-931-30EA - Each71610-9318c3d5249-1c6e-4aaf-950f-d04661499da712025-09-12
71610-931-46EA - Each71610-931f0fe1827-aea3-405c-8708-9c5f95a68d1d12025-09-12
71610-931-53EA - Each71610-93195b8f229-1a96-4eab-8428-d36615b0ae4c12025-09-12
71610-931-54EA - Each71610-931be4ee996-2db0-441f-8cde-170404ec147712025-09-12
71610-931-60EA - Each71610-93139e730a3-3551-4c62-bfbf-e470024d94b812025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483442pregabalin 25 MG Oral CapsulePSN3ab57054-02c2-5e28-e063-6294a90a71ab1
483442pregabalin 25 MG Oral CapsuleSCD3ab57054-02c2-5e28-e063-6294a90a71ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-931-307161009313030 CAPSULE in 1 BOTTLE (71610-931-30) 30 capsule2025-07-24NoNoHistorical
71610-931-467161009314656 CAPSULE in 1 BOTTLE (71610-931-46) 56 capsule2025-07-24NoNoHistorical
71610-931-537161009315360 CAPSULE in 1 BOTTLE (71610-931-53) 60 capsule2025-07-24NoNoHistorical
71610-931-547161009315484 CAPSULE in 1 BOTTLE (71610-931-54) 84 capsule2025-07-24NoNoHistorical
71610-931-607161009316090 CAPSULE in 1 BOTTLE (71610-931-60) 90 capsule2025-07-24NoNoHistorical