Pregabalin

Product NDC
71335-9671
11-digit product format
713359671
Labeler code
71335
Product ID
71335-9671_72ce5ab1-1e1a-4d15-9a78-e4484574af70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208677
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
225 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
PREGABALIN225 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui577127

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9671-1Pregabalin30 in 1 BOTTLECAPSULE30104
71335-9671-2Pregabalin60 in 1 BOTTLECAPSULE60104
71335-9671-3Pregabalin90 in 1 BOTTLECAPSULE90104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9671PREGABALIN CAPSULE [BRYANT RANCH PREPACK]102Current NDC, 3 package rows20240727_1a8d8292-1f94-46da-bade-8c4054201343.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577127pregabalin 225 MG Oral CapsulePSN1a8d8292-1f94-46da-bade-8c4054201343104
577127pregabalin 225 MG Oral CapsuleSCD1a8d8292-1f94-46da-bade-8c4054201343104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9671-17133596710130 CAPSULE in 1 BOTTLE (71335-9671-1) 30 capsule2026-03-17NoNoHistorical
71335-9671-27133596710260 CAPSULE in 1 BOTTLE (71335-9671-2) 60 capsule2026-04-13NoNoHistorical
71335-9671-37133596710390 CAPSULE in 1 BOTTLE (71335-9671-3) 90 capsule2026-04-13NoNoHistorical