FDA.reportPublic FDA data

Lyrica

Product NDC
58151-238
11-digit product format
581510238
Labeler code
58151
Product ID
58151-238_1c2af07d-faf4-4fc7-b724-c5166746956d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA021446
Marketing category
NDA
Marketing start
2025-06-17
Substance
PREGABALIN
Active strength
75 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
Lyrica
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, 607022, 607024, 607026, 607028, 607033, 607038, 898715, 898718

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58151-238-32Lyrica1 in 1 BLISTER PACKCAPSULE118
58151-238-77Lyrica90 in 1 BOTTLECAPSULE9018
58151-238-88Lyrica100 in 1 CARTONCAPSULE10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-238-32EA - Each58151-238f9f0e761-1631-49e0-83f9-ad0e295b8ff312025-10-14
58151-238-77EA - Each58151-23893023ac9-b69d-4965-aba3-800bca9591bf12025-07-08
58151-238-88EA - Each58151-238be4cfc85-8730-417d-83b7-ec1c7e35ee4812025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-238LYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [VIATRIS SPECIALTY LLC]11Current NDC, 3 package rows20250510_d4734e7d-5079-455e-8ff5-8f4539c998a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
607018Lyrica 100 MG Oral CapsulePSNd4734e7d-5079-455e-8ff5-8f4539c998a918
607020Lyrica 150 MG Oral CapsulePSNd4734e7d-5079-455e-8ff5-8f4539c998a918
898718Lyrica 20 MG in 1 mL Oral SolutionPSNd4734e7d-5079-455e-8ff5-8f4539c998a918
607022Lyrica 200 MG Oral CapsulePSNd4734e7d-5079-455e-8ff5-8f4539c998a918
607024Lyrica 225 MG Oral CapsulePSNd4734e7d-5079-455e-8ff5-8f4539c998a918
607026Lyrica 25 MG Oral CapsulePSNd4734e7d-5079-455e-8ff5-8f4539c998a918
607028Lyrica 300 MG Oral CapsulePSNd4734e7d-5079-455e-8ff5-8f4539c998a918
607033Lyrica 50 MG Oral CapsulePSNd4734e7d-5079-455e-8ff5-8f4539c998a918
607038Lyrica 75 MG Oral CapsulePSNd4734e7d-5079-455e-8ff5-8f4539c998a918
483438pregabalin 100 MG Oral CapsulePSNd4734e7d-5079-455e-8ff5-8f4539c998a918
483440pregabalin 150 MG Oral CapsulePSNd4734e7d-5079-455e-8ff5-8f4539c998a918
898715pregabalin 20 MG in 1 mL Oral SolutionPSNd4734e7d-5079-455e-8ff5-8f4539c998a918
483446pregabalin 200 MG Oral CapsulePSNd4734e7d-5079-455e-8ff5-8f4539c998a918
577127pregabalin 225 MG Oral CapsulePSNd4734e7d-5079-455e-8ff5-8f4539c998a918
483442pregabalin 25 MG Oral CapsulePSNd4734e7d-5079-455e-8ff5-8f4539c998a918
483444pregabalin 300 MG Oral CapsulePSNd4734e7d-5079-455e-8ff5-8f4539c998a918
483448pregabalin 50 MG Oral CapsulePSNd4734e7d-5079-455e-8ff5-8f4539c998a918
483450pregabalin 75 MG Oral CapsulePSNd4734e7d-5079-455e-8ff5-8f4539c998a918
607018pregabalin 100 MG Oral Capsule [Lyrica]SBDd4734e7d-5079-455e-8ff5-8f4539c998a918
607020pregabalin 150 MG Oral Capsule [Lyrica]SBDd4734e7d-5079-455e-8ff5-8f4539c998a918
898718pregabalin 20 MG/ML Oral Solution [Lyrica]SBDd4734e7d-5079-455e-8ff5-8f4539c998a918
607022pregabalin 200 MG Oral Capsule [Lyrica]SBDd4734e7d-5079-455e-8ff5-8f4539c998a918
607024pregabalin 225 MG Oral Capsule [Lyrica]SBDd4734e7d-5079-455e-8ff5-8f4539c998a918
607026pregabalin 25 MG Oral Capsule [Lyrica]SBDd4734e7d-5079-455e-8ff5-8f4539c998a918
607028pregabalin 300 MG Oral Capsule [Lyrica]SBDd4734e7d-5079-455e-8ff5-8f4539c998a918
607033pregabalin 50 MG Oral Capsule [Lyrica]SBDd4734e7d-5079-455e-8ff5-8f4539c998a918
607038pregabalin 75 MG Oral Capsule [Lyrica]SBDd4734e7d-5079-455e-8ff5-8f4539c998a918
483438pregabalin 100 MG Oral CapsuleSCDd4734e7d-5079-455e-8ff5-8f4539c998a918
483440pregabalin 150 MG Oral CapsuleSCDd4734e7d-5079-455e-8ff5-8f4539c998a918
898715pregabalin 20 MG/ML Oral SolutionSCDd4734e7d-5079-455e-8ff5-8f4539c998a918
483446pregabalin 200 MG Oral CapsuleSCDd4734e7d-5079-455e-8ff5-8f4539c998a918
577127pregabalin 225 MG Oral CapsuleSCDd4734e7d-5079-455e-8ff5-8f4539c998a918
483442pregabalin 25 MG Oral CapsuleSCDd4734e7d-5079-455e-8ff5-8f4539c998a918
483444pregabalin 300 MG Oral CapsuleSCDd4734e7d-5079-455e-8ff5-8f4539c998a918
483448pregabalin 50 MG Oral CapsuleSCDd4734e7d-5079-455e-8ff5-8f4539c998a918
483450pregabalin 75 MG Oral CapsuleSCDd4734e7d-5079-455e-8ff5-8f4539c998a918
607018Lyrica 100 MG Oral CapsuleSYd4734e7d-5079-455e-8ff5-8f4539c998a918
607020Lyrica 150 MG Oral CapsuleSYd4734e7d-5079-455e-8ff5-8f4539c998a918
898718Lyrica 20 MG per 1 ML Oral SolutionSYd4734e7d-5079-455e-8ff5-8f4539c998a918
898718Lyrica 20 MG/ML Oral SolutionSYd4734e7d-5079-455e-8ff5-8f4539c998a918
607022Lyrica 200 MG Oral CapsuleSYd4734e7d-5079-455e-8ff5-8f4539c998a918
607024Lyrica 225 MG Oral CapsuleSYd4734e7d-5079-455e-8ff5-8f4539c998a918
607026Lyrica 25 MG Oral CapsuleSYd4734e7d-5079-455e-8ff5-8f4539c998a918
607028Lyrica 300 MG Oral CapsuleSYd4734e7d-5079-455e-8ff5-8f4539c998a918
607033Lyrica 50 MG Oral CapsuleSYd4734e7d-5079-455e-8ff5-8f4539c998a918
607038Lyrica 75 MG Oral CapsuleSYd4734e7d-5079-455e-8ff5-8f4539c998a918
898715pregabalin 20 MG per 1 ML Oral SolutionSYd4734e7d-5079-455e-8ff5-8f4539c998a918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58151-238-32581510238321 in 1 BLISTER PACKHistorical
58151-238-775815102387790 CAPSULE in 1 BOTTLE (58151-238-77) 90 capsule2025-06-17NoNoCurrent
58151-238-8858151023888100 BLISTER PACK in 1 CARTON (58151-238-88) / 1 CAPSULE in 1 BLISTER PACK (58151-238-32) 100 blister pack2025-09-24NoNoCurrent