FDA.reportPublic FDA data

Lyrica

Product NDC
68258-7980
11-digit product format
682587980
Labeler code
68258
Product ID
68258-7980_04ac4476-c8ce-4c16-a8d5-484492d52c5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
NDA021724
Marketing category
NDA
Marketing start
2004-12-30
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
75 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68258-7980IInactivated by FDA2026-07-31
excluded packagepackage68258-798068258-7980-9IInactivated 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
68258-7980-92019-11-27C16284748780-19855d018-ed23-cd31-e053-dbdaa90ab51aThese 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
68258-7980-9Lyrica90 in 1 BOTTLECAPSULE901

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREGABALINACTIVE INGREDIENT55JG375S6MLYRICA (PREGABALIN) CAPSULE [DISPENSING SOLUTIONS, INC.]1
PREGABALINACTIVE MOIETY55JG375S6MLYRICA (PREGABALIN) CAPSULE [DISPENSING SOLUTIONS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LYRICA (PREGABALIN) CAPSULE [DISPENSING SOLUTIONS, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LYRICA (PREGABALIN) CAPSULE [DISPENSING SOLUTIONS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LLYRICA (PREGABALIN) CAPSULE [DISPENSING SOLUTIONS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLYRICA (PREGABALIN) CAPSULE [DISPENSING SOLUTIONS, INC.]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLYRICA (PREGABALIN) CAPSULE [DISPENSING SOLUTIONS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LYRICA (PREGABALIN) CAPSULE [DISPENSING SOLUTIONS, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OLYRICA (PREGABALIN) CAPSULE [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LYRICA (PREGABALIN) CAPSULE [DISPENSING SOLUTIONS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLYRICA (PREGABALIN) CAPSULE [DISPENSING SOLUTIONS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLYRICA (PREGABALIN) CAPSULE [DISPENSING SOLUTIONS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULYRICA (PREGABALIN) CAPSULE [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLYRICA (PREGABALIN) CAPSULE [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-7980LYRICA (PREGABALIN) CAPSULE [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20130730_869d4092-6980-48b3-abc8-37bf3e5a9510.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
607038Lyrica 75 MG Oral CapsulePSN869d4092-6980-48b3-abc8-37bf3e5a95101
483450pregabalin 75 MG Oral CapsulePSN869d4092-6980-48b3-abc8-37bf3e5a95101
607038pregabalin 75 MG Oral Capsule [Lyrica]SBD869d4092-6980-48b3-abc8-37bf3e5a95101
483450pregabalin 75 MG Oral CapsuleSCD869d4092-6980-48b3-abc8-37bf3e5a95101
607038Lyrica 75 MG Oral CapsuleSY869d4092-6980-48b3-abc8-37bf3e5a95101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-7980-96825879800990 in 1 BOTTLEHistorical