FDA.reportPublic FDA data

Pregabalin

Product NDC
69367-325
11-digit product format
693670325
Labeler code
69367
Product ID
69367-325_0efc2eea-ebae-47f9-a13a-f2df4331cf04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA208677
Marketing category
ANDA
Marketing start
2021-08-24
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
Rxcui483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-325-09Pregabalin90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-325-09EA - Each69367-3257bc85ed8-75ab-4988-b0a3-42753fb0a40212021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-325PREGABALIN CAPSULE [WESTMINSTER PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20240405_781cb1ac-a0d2-4b47-b319-f0b90de86384.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN781cb1ac-a0d2-4b47-b319-f0b90de863843
483440pregabalin 150 MG Oral CapsulePSN781cb1ac-a0d2-4b47-b319-f0b90de863843
483446pregabalin 200 MG Oral CapsulePSN781cb1ac-a0d2-4b47-b319-f0b90de863843
577127pregabalin 225 MG Oral CapsulePSN781cb1ac-a0d2-4b47-b319-f0b90de863843
483442pregabalin 25 MG Oral CapsulePSN781cb1ac-a0d2-4b47-b319-f0b90de863843
483444pregabalin 300 MG Oral CapsulePSN781cb1ac-a0d2-4b47-b319-f0b90de863843
483448pregabalin 50 MG Oral CapsulePSN781cb1ac-a0d2-4b47-b319-f0b90de863843
483448pregabalin 50 MG Oral CapsulePSN10e1c465-5cc4-403a-9c70-41dafc354dba3
483450pregabalin 75 MG Oral CapsulePSN10e1c465-5cc4-403a-9c70-41dafc354dba3
483450pregabalin 75 MG Oral CapsulePSN781cb1ac-a0d2-4b47-b319-f0b90de863843
483438pregabalin 100 MG Oral CapsuleSCD781cb1ac-a0d2-4b47-b319-f0b90de863843
483440pregabalin 150 MG Oral CapsuleSCD781cb1ac-a0d2-4b47-b319-f0b90de863843
483446pregabalin 200 MG Oral CapsuleSCD781cb1ac-a0d2-4b47-b319-f0b90de863843
577127pregabalin 225 MG Oral CapsuleSCD781cb1ac-a0d2-4b47-b319-f0b90de863843
483442pregabalin 25 MG Oral CapsuleSCD781cb1ac-a0d2-4b47-b319-f0b90de863843
483444pregabalin 300 MG Oral CapsuleSCD781cb1ac-a0d2-4b47-b319-f0b90de863843
483448pregabalin 50 MG Oral CapsuleSCD781cb1ac-a0d2-4b47-b319-f0b90de863843
483448pregabalin 50 MG Oral CapsuleSCD10e1c465-5cc4-403a-9c70-41dafc354dba3
483450pregabalin 75 MG Oral CapsuleSCD781cb1ac-a0d2-4b47-b319-f0b90de863843
483450pregabalin 75 MG Oral CapsuleSCD10e1c465-5cc4-403a-9c70-41dafc354dba3
483438pregabalin 100 MG Oral CapsulePSN9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483440pregabalin 150 MG Oral CapsulePSN9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483446pregabalin 200 MG Oral CapsulePSN9b1472ac-8b79-4f22-ae50-3b0942bd62b12
577127pregabalin 225 MG Oral CapsulePSN9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483442pregabalin 25 MG Oral CapsulePSN9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483444pregabalin 300 MG Oral CapsulePSN9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483448pregabalin 50 MG Oral CapsulePSN9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483450pregabalin 75 MG Oral CapsulePSN9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483438pregabalin 100 MG Oral CapsuleSCD9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483440pregabalin 150 MG Oral CapsuleSCD9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483446pregabalin 200 MG Oral CapsuleSCD9b1472ac-8b79-4f22-ae50-3b0942bd62b12
577127pregabalin 225 MG Oral CapsuleSCD9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483442pregabalin 25 MG Oral CapsuleSCD9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483444pregabalin 300 MG Oral CapsuleSCD9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483448pregabalin 50 MG Oral CapsuleSCD9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483450pregabalin 75 MG Oral CapsuleSCD9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483448pregabalin 50 MG Oral CapsulePSN137ffe30-ff8b-409d-a719-6be19d4d95221
483448pregabalin 50 MG Oral CapsulePSN3ab4efb3-1ae5-2504-e063-6294a90a6d1d1
483448pregabalin 50 MG Oral CapsuleSCD137ffe30-ff8b-409d-a719-6be19d4d95221
483448pregabalin 50 MG Oral CapsuleSCD3ab4efb3-1ae5-2504-e063-6294a90a6d1d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-325-096936703250990 CAPSULE in 1 BOTTLE (69367-325-09) 90 capsule2021-08-240000-00-00NoNoCurrent