FDA.reportPublic FDA data

Pregabalin

Product NDC
71610-719
11-digit product format
716100719
Labeler code
71610
Product ID
71610-719_4a1acfd2-c440-9cc4-e063-6394a90a1c09
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
150 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
PREGABALIN150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483440

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
71610-719-30Pregabalin30 in 1 BOTTLECAPSULE303
71610-719-46Pregabalin56 in 1 BOTTLECAPSULE563
71610-719-53Pregabalin60 in 1 BOTTLECAPSULE603
71610-719-70Pregabalin120 in 1 BOTTLECAPSULE1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-719-46EA - Each71610-719a1341cf3-cc5d-4385-b86f-5ee77ddc84cb12026-03-17
71610-719-53EA - Each71610-7190295c99b-fef5-43ea-a792-8ad31d6dfb8d12023-12-05
71610-719-70EA - Each71610-719ccbedf85-e3e3-486e-81a2-93e44391194e12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-719PREGABALIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 4 package rows20230718_99c3d252-4d51-4679-aa61-e2d0b8238b38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483440pregabalin 150 MG Oral CapsulePSN99c3d252-4d51-4679-aa61-e2d0b8238b383
483440pregabalin 150 MG Oral CapsuleSCD99c3d252-4d51-4679-aa61-e2d0b8238b383

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-719-307161007193030 CAPSULE in 1 BOTTLE (71610-719-30) 30 capsule2023-06-30NoNoHistorical
71610-719-467161007194656 CAPSULE in 1 BOTTLE (71610-719-46) 56 capsule2026-02-03NoNoHistorical
71610-719-537161007195360 CAPSULE in 1 BOTTLE (71610-719-53) 60 capsule2023-06-30NoNoHistorical
71610-719-7071610071970120 CAPSULE in 1 BOTTLE (71610-719-70) 120 capsule2023-07-14NoNoHistorical