FDA.reportPublic FDA data

Pregabalin Extended Release

Product NDC
50228-462
11-digit product format
502280462
Labeler code
50228
Product ID
50228-462_e90bfe09-9adb-03c0-e053-2a95a90a061e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
ScieGen Pharmaceuticals, INC.
Application
ANDA215675
Marketing category
ANDA
Marketing start
2022-09-14
Substance
PREGABALIN
Active strength
82.5 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 Extended Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN82.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui1988974, 1988977, 1988980

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
50228-462-05Pregabalin Extended Release500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5001
50228-462-30Pregabalin Extended Release30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-462PREGABALIN EXTENDED RELEASE (PREGABALIN) TABLET, FILM COATED, EXTENDED RELEASE [SCIEGEN PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 2 package rows20220920_1544a657-353c-47f8-96ac-a63fa78373f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1988974pregabalin 165 MG 24HR Extended Release Oral TabletPSN1544a657-353c-47f8-96ac-a63fa78373f01
1988977pregabalin 330 MG 24HR Extended Release Oral TabletPSN1544a657-353c-47f8-96ac-a63fa78373f01
1988980pregabalin 82.5 MG 24HR Extended Release Oral TabletPSN1544a657-353c-47f8-96ac-a63fa78373f01
198897424 HR pregabalin 165 MG Extended Release Oral TabletSCD1544a657-353c-47f8-96ac-a63fa78373f01
198897724 HR pregabalin 330 MG Extended Release Oral TabletSCD1544a657-353c-47f8-96ac-a63fa78373f01
198898024 HR pregabalin 82.5 MG Extended Release Oral TabletSCD1544a657-353c-47f8-96ac-a63fa78373f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50228-462-0550228046205500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-462-05) 2022-09-140000-00-00NoNoCurrent
50228-462-305022804623030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-462-30) 2022-09-140000-00-00NoNoCurrent