FDA.reportPublic FDA data

Lyrica

Product NDC
58151-243
11-digit product format
581510243
Labeler code
58151
Product ID
58151-243_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
2025-05-08
Substance
PREGABALIN
Active strength
225 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
PREGABALIN225 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
58151-243-77Lyrica90 in 1 BOTTLECAPSULE9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-243-77EA - Each58151-2438b53d0e6-c9d6-47ed-8efa-0ccf1862cead12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-243LYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [VIATRIS SPECIALTY LLC]11Current NDC, 1 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
58151-243-775815102437790 CAPSULE in 1 BOTTLE (58151-243-77) 90 capsule2025-05-08NoNoCurrent