FDA.reportPublic FDA data

Pregabalin

Product NDC
45865-107
11-digit product format
458650107
Labeler code
45865
Product ID
45865-107_b6dd6455-013d-49b3-e053-2995a90af99e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA208677
Marketing category
ANDA
Marketing start
2020-07-02
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
75 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-107-302026-01-29C16284748780-1f386c64a-2db0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. <footnote ID=""/> <br/> <br/> <br/> <br/> PREGABALIN capsules, for oral use CV <br/> <br/> <br/> <br/> Initial U.S. Approval: 2004 <title/>
45865-107-902026-01-29C16284748780-1f386c64a-2db0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. <footnote ID=""/> <br/> <br/> <br/> <br/> PREGABALIN capsules, for oral use CV <br/> <br/> <br/> <br/> Initial U.S. Approval: 2004 <title/>
45865-107-302024-02-28C16284748780-1f386c64a-2db0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. <footnote ID=""/> <br/> <br/> <br/> <br/> PREGABALIN capsules, for oral use CV <br/> <br/> <br/> <br/> Initial U.S. Approval: 2004 <title/>
45865-107-902024-02-28C16284748780-1f386c64a-2db0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. <footnote ID=""/> <br/> <br/> <br/> <br/> PREGABALIN capsules, for oral use CV <br/> <br/> <br/> <br/> Initial U.S. Approval: 2004 <title/>
45865-107-302023-01-30C16284748780-1f386c64a-2db0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. <footnote ID=""/> <br/> <br/> <br/> <br/> PREGABALIN capsules, for oral use CV <br/> <br/> <br/> <br/> Initial U.S. Approval: 2004 <title/>
45865-107-902023-01-30C16284748780-1f386c64a-2db0-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. <footnote ID=""/> <br/> <br/> <br/> <br/> PREGABALIN capsules, for oral use CV <br/> <br/> <br/> <br/> Initial U.S. Approval: 2004 <title/>

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-107-30Pregabalin30 in 1 BOTTLECAPSULE302
45865-107-90Pregabalin90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-107PREGABALIN CAPSULE [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 2 package rows20240301_b6dd6455-013c-49b3-e053-2995a90af99e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483450pregabalin 75 MG Oral CapsulePSNb6dd6455-013c-49b3-e053-2995a90af99e2
483450pregabalin 75 MG Oral CapsuleSCDb6dd6455-013c-49b3-e053-2995a90af99e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-107-304586501073030 CAPSULE in 1 BOTTLE (45865-107-30) 30 capsule2020-07-020000-00-00NoNoCurrent
45865-107-904586501079090 CAPSULE in 1 BOTTLE (45865-107-90) 90 capsule2020-07-020000-00-00NoNoCurrent