FDA.reportPublic FDA data

Pregabalin

Product NDC
71610-993
11-digit product format
716100993
Labeler code
71610
Product ID
71610-993_5079b31b-577f-f0b7-e063-6294a90af6b6
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
2025-12-10
Substance
PREGABALIN
Active strength
25 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pregabalin
Listing expiration
2027-12-31

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
71610-993-30Pregabalin30 in 1 BOTTLECAPSULE302
71610-993-53Pregabalin60 in 1 BOTTLECAPSULE602
71610-993-60Pregabalin90 in 1 BOTTLECAPSULE902
71610-993-70Pregabalin120 in 1 BOTTLECAPSULE1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-993-30EA - Each71610-99300124635-ead4-4f76-8d8f-67e6e68d8a6b12026-04-20
71610-993-53EA - Each71610-993693be815-168f-4128-9208-76b644c74d9612026-04-20
71610-993-60EA - Each71610-99394050cd1-6a44-4807-817e-742062016bb012026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483442pregabalin 25 MG Oral CapsulePSN4d53c8e2-f03f-0f5b-e063-6294a90a23c62
483442pregabalin 25 MG Oral CapsuleSCD4d53c8e2-f03f-0f5b-e063-6294a90a23c62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-993-307161009933030 CAPSULE in 1 BOTTLE (71610-993-30) 30 capsule2026-03-18NoNoHistorical
71610-993-537161009935360 CAPSULE in 1 BOTTLE (71610-993-53) 60 capsule2026-03-18NoNoHistorical
71610-993-607161009936090 CAPSULE in 1 BOTTLE (71610-993-60) 90 capsule2026-03-18NoNoHistorical
71610-993-7071610099370120 CAPSULE in 1 BOTTLE (71610-993-70) 120 capsule2026-04-27NoNoHistorical