FDA.reportPublic FDA data

PREGABALIN

Product NDC
71335-1300
11-digit product format
713351300
Labeler code
71335
Product ID
71335-1300_fff97376-7943-4a37-80b9-7d6ebd334716
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210432
Marketing category
ANDA
Marketing start
2019-07-19
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
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1300-12024-05-20C16284748780-11030e365-5a7a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71335-1300-22024-05-20C16284748780-11030e365-5a7a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71335-1300-32024-05-20C16284748780-11030e365-5a7a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71335-1300-12024-01-30C16284748780-11030e365-5a7a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71335-1300-22024-01-30C16284748780-11030e365-5a7a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71335-1300-32024-01-30C16284748780-11030e365-5a7a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1300-1PREGABALIN30 in 1 BOTTLECAPSULE3014
71335-1300-2PREGABALIN60 in 1 BOTTLECAPSULE6014
71335-1300-3PREGABALIN90 in 1 BOTTLECAPSULE9014
71335-1300-4PREGABALIN15 in 1 BOTTLECAPSULE1514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1300-1EA - Each71335-13000109797b-821f-494c-bab4-3124b1f4639312019-10-07
71335-1300-3EA - Each71335-13006f07a80f-55d2-4082-8e58-2c0ea386428412019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1300PREGABALIN CAPSULE [BRYANT RANCH PREPACK]13Current NDC, Legacy NDC, 4 package rows20240522_72832f05-325e-4a72-8a33-da114e39c52d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483448pregabalin 50 MG Oral CapsulePSN72832f05-325e-4a72-8a33-da114e39c52d14
483448pregabalin 50 MG Oral CapsuleSCD72832f05-325e-4a72-8a33-da114e39c52d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1300-17133513000130 CAPSULE in 1 BOTTLE (71335-1300-1) 30 capsule2019-08-120000-00-00NoNoCurrent
71335-1300-27133513000260 CAPSULE in 1 BOTTLE (71335-1300-2) 60 capsule2024-05-170000-00-00NoNoCurrent
71335-1300-37133513000390 CAPSULE in 1 BOTTLE (71335-1300-3) 90 capsule2019-08-130000-00-00NoNoCurrent
71335-1300-47133513000415 CAPSULE in 1 BOTTLE (71335-1300-4) 15 capsule2024-05-17NoNoHistorical