Pregabalin

Product NDC
71335-2339
11-digit product format
713352339
Labeler code
71335
Product ID
71335-2339_7c52e39f-79ad-4ffa-95df-f66fc4c48113
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
75 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
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
71335-2339-1Pregabalin30 in 1 BOTTLECAPSULE30102
71335-2339-2Pregabalin60 in 1 BOTTLECAPSULE60102
71335-2339-3Pregabalin90 in 1 BOTTLECAPSULE90102
71335-2339-4Pregabalin120 in 1 BOTTLECAPSULE120102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2339PREGABALIN CAPSULE [BRYANT RANCH PREPACK]101Current NDC, 4 package rows20240726_45abbcb4-6a38-469d-9671-24b2c25e5b18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483450pregabalin 75 MG Oral CapsulePSN45abbcb4-6a38-469d-9671-24b2c25e5b18102
483450pregabalin 75 MG Oral CapsuleSCD45abbcb4-6a38-469d-9671-24b2c25e5b18102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2339-17133523390130 CAPSULE in 1 BOTTLE (71335-2339-1) 30 capsule2024-07-16NoNoHistorical
71335-2339-27133523390260 CAPSULE in 1 BOTTLE (71335-2339-2) 60 capsule2024-07-16NoNoHistorical
71335-2339-37133523390390 CAPSULE in 1 BOTTLE (71335-2339-3) 90 capsule2024-07-16NoNoHistorical
71335-2339-471335233904120 CAPSULE in 1 BOTTLE (71335-2339-4) 120 capsule2024-07-16NoNoHistorical