FDA.reportPublic FDA data

Lyrica

Product NDC
52959-891
11-digit product format
529590891
Labeler code
52959
Product ID
52959-891_4c9b2c15-78b0-42b1-a146-026282c33076
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
NDA021724
Marketing category
NDA
Marketing start
2004-12-30
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
50 mg/1
DEA schedule
CV
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-891IInactivated by FDA2026-07-31
excluded packagepackage52959-89152959-891-02IInactivated by FDA2026-07-31
excluded packagepackage52959-89152959-891-30IInactivated by FDA2026-07-31
excluded packagepackage52959-89152959-891-60IInactivated by FDA2026-07-31
excluded packagepackage52959-89152959-891-90IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog.

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
52959-891-022019-11-13C16284748780-197449f38-bd20-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004
52959-891-302019-11-13C16284748780-197449f38-bd20-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004
52959-891-602019-11-13C16284748780-197449f38-bd20-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004
52959-891-902019-11-13C16284748780-197449f38-bd20-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-891-02Lyrica120 in 1 BOTTLECAPSULE1204
52959-891-30Lyrica30 in 1 BLISTER PACKCAPSULE304
52959-891-60Lyrica60 in 1 BOTTLECAPSULE604
52959-891-90Lyrica90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-891-02EA - Each52959-89187998e2f-2a0a-4a14-8738-b7f1aaceab4912012-07-24
52959-891-30EA - Each52959-891e513ebdf-5cff-471d-8f28-163f3587ab9c12012-07-24
52959-891-60EA - Each52959-8914dc07e12-f223-4039-8993-88764034a81c12012-07-24
52959-891-90EA - Each52959-891418b0a39-9264-4a68-9bca-9b65be07e13a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREGABALINACTIVE INGREDIENT55JG375S6MLYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]4
PREGABALINACTIVE MOIETY55JG375S6MLYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]4
GELATININACTIVE INGREDIENT2G86QN327LLYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OLYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1ULYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-891LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]4Legacy NDC, 4 package rows20111019_a262d7c6-2aa9-433c-b801-d8b2dcd68a0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
607018Lyrica 100 MG Oral CapsulePSNa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
607020Lyrica 150 MG Oral CapsulePSNa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
607033Lyrica 50 MG Oral CapsulePSNa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
607038Lyrica 75 MG Oral CapsulePSNa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
483438pregabalin 100 MG Oral CapsulePSNa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
483440pregabalin 150 MG Oral CapsulePSNa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
483448pregabalin 50 MG Oral CapsulePSNa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
483450pregabalin 75 MG Oral CapsulePSNa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
607018pregabalin 100 MG Oral Capsule [Lyrica]SBDa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
607020pregabalin 150 MG Oral Capsule [Lyrica]SBDa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
607033pregabalin 50 MG Oral Capsule [Lyrica]SBDa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
607038pregabalin 75 MG Oral Capsule [Lyrica]SBDa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
483438pregabalin 100 MG Oral CapsuleSCDa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
483440pregabalin 150 MG Oral CapsuleSCDa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
483448pregabalin 50 MG Oral CapsuleSCDa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
483450pregabalin 75 MG Oral CapsuleSCDa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
607018Lyrica 100 MG Oral CapsuleSYa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
607020Lyrica 150 MG Oral CapsuleSYa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
607033Lyrica 50 MG Oral CapsuleSYa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4
607038Lyrica 75 MG Oral CapsuleSYa262d7c6-2aa9-433c-b801-d8b2dcd68a0f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-891-0252959089102120 in 1 BOTTLEHistorical
52959-891-305295908913030 in 1 BLISTER PACKHistorical
52959-891-605295908916060 in 1 BOTTLEHistorical
52959-891-905295908919090 in 1 BOTTLEHistorical