Pregabalin

Product NDC
45865-106
11-digit product format
458650106
Labeler code
45865
Product ID
45865-106_b534c542-021d-98e9-e053-2a95a90a22fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA208677
Marketing category
ANDA
Marketing start
2020-07-01
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
50 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-106-30Pregabalin30 in 1 BOTTLECAPSULE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-106PREGABALIN CAPSULE [MEDSOURCE PHARMACEUTICALS]3Legacy NDC, 1 package rows20240228_b534c542-021c-98e9-e053-2a95a90a22fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483448pregabalin 50 MG Oral CapsulePSNb534c542-021c-98e9-e053-2a95a90a22fa3
483448pregabalin 50 MG Oral CapsuleSCDb534c542-021c-98e9-e053-2a95a90a22fa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-106-304586501063030 CAPSULE in 1 BOTTLE (45865-106-30) 30 capsule2020-07-010000-00-00NoNoCurrent