FDA.reportPublic FDA data

Pregabalin

Product NDC
76282-571
11-digit product format
762820571
Labeler code
76282
Product ID
76282-571_b26b72af-62e4-4eb5-9cb8-e4eb05a22435
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
Application
ANDA211384
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
100 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
PREGABALIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76282-571-052023-03-23C16284748780-1f386c649-c583-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
76282-571-902023-03-23C16284748780-1f386c649-c583-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
76282-571-052023-01-30C16284748780-1f386c649-c583-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
76282-571-902023-01-30C16284748780-1f386c649-c583-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-571-05Pregabalin500 in 1 BOTTLECAPSULE5005
76282-571-90Pregabalin90 in 1 BOTTLECAPSULE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-571PREGABALIN CAPSULE [EXELAN PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20230324_3fdc6e94-2504-416c-81dd-2db9bc194ebb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483440pregabalin 150 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483446pregabalin 200 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
577127pregabalin 225 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483442pregabalin 25 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483444pregabalin 300 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483448pregabalin 50 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483450pregabalin 75 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483438pregabalin 100 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483440pregabalin 150 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483446pregabalin 200 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
577127pregabalin 225 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483442pregabalin 25 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483444pregabalin 300 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483448pregabalin 50 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483450pregabalin 75 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483438pregabalin 100 MG Oral CapsulePSN3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483440pregabalin 150 MG Oral CapsulePSN3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483446pregabalin 200 MG Oral CapsulePSN3fdc6e94-2504-416c-81dd-2db9bc194ebb5
577127pregabalin 225 MG Oral CapsulePSN3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483442pregabalin 25 MG Oral CapsulePSN3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483444pregabalin 300 MG Oral CapsulePSN3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483448pregabalin 50 MG Oral CapsulePSN3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483450pregabalin 75 MG Oral CapsulePSN3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483438pregabalin 100 MG Oral CapsuleSCD3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483440pregabalin 150 MG Oral CapsuleSCD3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483446pregabalin 200 MG Oral CapsuleSCD3fdc6e94-2504-416c-81dd-2db9bc194ebb5
577127pregabalin 225 MG Oral CapsuleSCD3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483442pregabalin 25 MG Oral CapsuleSCD3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483444pregabalin 300 MG Oral CapsuleSCD3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483448pregabalin 50 MG Oral CapsuleSCD3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483450pregabalin 75 MG Oral CapsuleSCD3fdc6e94-2504-416c-81dd-2db9bc194ebb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-571-0576282057105500 CAPSULE in 1 BOTTLE (76282-571-05) 500 capsule2019-07-190000-00-00NoNoCurrent
76282-571-907628205719090 CAPSULE in 1 BOTTLE (76282-571-90) 90 capsule2019-07-190000-00-00NoNoCurrent