PREGABALIN

Product NDC
71205-298
11-digit product format
712050298
Labeler code
71205
Product ID
71205-298_6c2bf577-88ce-4344-b1ba-b28b5a3d2e86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA210432
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
75 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
PREGABALIN75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483450

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
71205-298-30PREGABALIN30 in 1 BOTTLECAPSULE302
71205-298-60PREGABALIN60 in 1 BOTTLECAPSULE602
71205-298-90PREGABALIN90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-298PREGABALIN CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20191005_6022939f-92a8-4cb4-9f04-f237a4d73f6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483450pregabalin 75 MG Oral CapsulePSN6022939f-92a8-4cb4-9f04-f237a4d73f6f2
483450pregabalin 75 MG Oral CapsuleSCD6022939f-92a8-4cb4-9f04-f237a4d73f6f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-298-307120502983030 CAPSULE in 1 BOTTLE (71205-298-30) 30 capsule2019-08-010000-00-00NoNoCurrent
71205-298-607120502986060 CAPSULE in 1 BOTTLE (71205-298-60) 60 capsule2019-08-010000-00-00NoNoCurrent
71205-298-907120502989090 CAPSULE in 1 BOTTLE (71205-298-90) 90 capsule2019-08-010000-00-00NoNoCurrent