FDA.reportPublic FDA data

Pregabalin

Product NDC
71610-887
11-digit product format
716100887
Labeler code
71610
Product ID
71610-887_0b556ed7-7827-40f7-b8fe-4bdf13e8f08c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA209357
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
300 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
PREGABALIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483444

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
71610-887-30Pregabalin30 in 1 BOTTLECAPSULE301
71610-887-46Pregabalin56 in 1 BOTTLECAPSULE561
71610-887-53Pregabalin60 in 1 BOTTLECAPSULE601
71610-887-60Pregabalin90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-887-30EA - Each71610-88743c23bfb-c40b-403f-a507-4d85e7895c0412025-06-13
71610-887-46EA - Each71610-88787290bf7-133c-47ff-b9b8-033d1e04e85f12025-06-13
71610-887-53EA - Each71610-887f39e0b07-b07e-4c21-84cc-1990c73ef38c12025-06-13
71610-887-60EA - Each71610-8878905722d-a20e-42b8-8882-43f45923f0f112025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-887PREGABALIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 4 package rows20250326_b1f4b888-ac88-4250-8db1-706e7cc01e93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483444pregabalin 300 MG Oral CapsulePSNb1f4b888-ac88-4250-8db1-706e7cc01e931
483444pregabalin 300 MG Oral CapsuleSCDb1f4b888-ac88-4250-8db1-706e7cc01e931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-887-307161008873030 CAPSULE in 1 BOTTLE (71610-887-30) 30 capsule2025-03-18NoNoHistorical
71610-887-467161008874656 CAPSULE in 1 BOTTLE (71610-887-46) 56 capsule2025-03-18NoNoHistorical
71610-887-537161008875360 CAPSULE in 1 BOTTLE (71610-887-53) 60 capsule2025-03-18NoNoHistorical
71610-887-607161008876090 CAPSULE in 1 BOTTLE (71610-887-60) 90 capsule2025-03-18NoNoHistorical