FDA.reportPublic FDA data

Pregabalin

Product NDC
71610-845
11-digit product format
716100845
Labeler code
71610
Product ID
71610-845_076a2ad0-6afe-43d8-a6fe-7058acc4ea92
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
150 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
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
71610-845-30Pregabalin30 in 1 BOTTLECAPSULE301
71610-845-46Pregabalin56 in 1 BOTTLECAPSULE561
71610-845-53Pregabalin60 in 1 BOTTLECAPSULE601
71610-845-54Pregabalin84 in 1 BOTTLECAPSULE841
71610-845-70Pregabalin120 in 1 BOTTLECAPSULE1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-845-30EA - Each71610-84509cd4bf9-2594-41ad-8270-497230c1b69b12024-09-09
71610-845-46EA - Each71610-845410e9a87-b5fe-4a02-b306-69dcde7fbbd212024-09-09
71610-845-53EA - Each71610-845ce7bfc52-b73c-4d66-a04f-ae33fe2f008612024-09-09
71610-845-54EA - Each71610-8458b0990c3-ec22-4a10-ae7b-76d40444b1a512024-09-09
71610-845-70EA - Each71610-84580051374-cbba-4964-81af-52c52f1c0ddb12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-845PREGABALIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 5 package rows20240730_8bb9495e-1354-4a70-baa5-9b80eb3518c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483440pregabalin 150 MG Oral CapsulePSN8bb9495e-1354-4a70-baa5-9b80eb3518c81
483440pregabalin 150 MG Oral CapsuleSCD8bb9495e-1354-4a70-baa5-9b80eb3518c81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-845-307161008453030 CAPSULE in 1 BOTTLE (71610-845-30) 30 capsule2024-07-16NoNoHistorical
71610-845-467161008454656 CAPSULE in 1 BOTTLE (71610-845-46) 56 capsule2024-07-16NoNoHistorical
71610-845-537161008455360 CAPSULE in 1 BOTTLE (71610-845-53) 60 capsule2024-07-16NoNoHistorical
71610-845-547161008455484 CAPSULE in 1 BOTTLE (71610-845-54) 84 capsule2024-07-16NoNoHistorical
71610-845-7071610084570120 CAPSULE in 1 BOTTLE (71610-845-70) 120 capsule2024-07-16NoNoHistorical