FDA.reportPublic FDA data

Pregabalin

Product NDC
71335-1790
11-digit product format
713351790
Labeler code
71335
Product ID
71335-1790_b48964fa-6989-42b3-84f5-5368f66bdc6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206912
Marketing category
ANDA
Marketing start
2019-10-08
Substance
PREGABALIN
Active strength
50 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
PREGABALIN50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483448

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1790-1Pregabalin30 in 1 BOTTLECAPSULE30104
71335-1790-2Pregabalin60 in 1 BOTTLECAPSULE60104
71335-1790-3Pregabalin90 in 1 BOTTLECAPSULE90104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1790-1EA - Each71335-1790fda47ec3-e411-4068-aa83-e941193b15a312021-09-07
71335-1790-2EA - Each71335-179054704c2c-7607-44e8-b99b-62bbc6cd057412021-09-07
71335-1790-3EA - Each71335-17903efaebc7-d729-47a3-9ef2-e46f78b0d22412021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1790PREGABALIN CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 3 package rows20240829_48798c13-3ef4-4e7f-9f73-92dccac0af14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483448pregabalin 50 MG Oral CapsulePSN48798c13-3ef4-4e7f-9f73-92dccac0af14104
483448pregabalin 50 MG Oral CapsuleSCD48798c13-3ef4-4e7f-9f73-92dccac0af14104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1790-17133517900130 CAPSULE in 1 BOTTLE (71335-1790-1) 30 capsule2021-03-030000-00-00NoNoCurrent
71335-1790-27133517900260 CAPSULE in 1 BOTTLE (71335-1790-2) 60 capsule2021-03-050000-00-00NoNoCurrent
71335-1790-37133517900390 CAPSULE in 1 BOTTLE (71335-1790-3) 90 capsule2021-03-030000-00-00NoNoCurrent