FDA.reportPublic FDA data

Pregabalin

Product NDC
71610-994
11-digit product format
716100994
Labeler code
71610
Product ID
71610-994_4ef50a7d-0ef7-25c9-e063-6394a90abbce
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
100 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
PREGABALIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483438

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
71610-994-30Pregabalin30 in 1 BOTTLECAPSULE302
71610-994-46Pregabalin56 in 1 BOTTLECAPSULE562
71610-994-53Pregabalin60 in 1 BOTTLECAPSULE602
71610-994-70Pregabalin120 in 1 BOTTLECAPSULE1202
71610-994-92Pregabalin270 in 1 BOTTLECAPSULE2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-994-30EA - Each71610-994a8c4b757-5ec7-4e33-807f-3982317e3c0812026-04-20
71610-994-46EA - Each71610-9945db9cb70-9162-4f78-82e4-4e584320801f12026-04-20
71610-994-53EA - Each71610-994211428ed-114e-4038-9265-762c3edb575112026-04-20
71610-994-70EA - Each71610-99481f3fde0-ac53-45d6-a3c1-3acbe02166ce12026-05-22
71610-994-92EA - Each71610-99448dd6e94-ac35-4a76-b7cf-fd798a4dfade12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN4d63908b-96be-554c-e063-6394a90af5102
483438pregabalin 100 MG Oral CapsuleSCD4d63908b-96be-554c-e063-6394a90af5102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-994-307161009943030 CAPSULE in 1 BOTTLE (71610-994-30) 30 capsule2026-03-19NoNoHistorical
71610-994-467161009944656 CAPSULE in 1 BOTTLE (71610-994-46) 56 capsule2026-03-19NoNoHistorical
71610-994-537161009945360 CAPSULE in 1 BOTTLE (71610-994-53) 60 capsule2026-03-19NoNoHistorical
71610-994-7071610099470120 CAPSULE in 1 BOTTLE (71610-994-70) 120 capsule2026-04-07NoNoHistorical
71610-994-9271610099492270 CAPSULE in 1 BOTTLE (71610-994-92) 270 capsule2026-03-19NoNoHistorical