Lyrica

Product NDC
50436-6523
11-digit product format
504366523
Labeler code
50436
Product ID
50436-6523_47c0794e-bc06-446f-a3e8-e5749d4a9284
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
NDA021446
Marketing category
NDA
Marketing start
2004-12-30
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
75 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-6523-1Lyrica30 in 1 BOTTLECAPSULE308
50436-6523-2Lyrica60 in 1 BOTTLECAPSULE608
50436-6523-3Lyrica90 in 1 BOTTLECAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-6523-1EA - Each50436-6523eb02e8e2-21e7-4cbd-856c-33954815f76912012-07-24
50436-6523-2EA - Each50436-65239f6705f8-b46e-4ea7-a533-8e23f775775712012-07-24
50436-6523-3EA - Each50436-6523219a2210-7b17-47fd-8bda-bc71b5b62ae712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREGABALINACTIVE INGREDIENT55JG375S6MLYRICA (PREGABALIN) CAPSULE [UNIT DOSE SERVICES]3
PREGABALINACTIVE MOIETY55JG375S6MLYRICA (PREGABALIN) CAPSULE [UNIT DOSE SERVICES]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LYRICA (PREGABALIN) CAPSULE [UNIT DOSE SERVICES]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LYRICA (PREGABALIN) CAPSULE [UNIT DOSE SERVICES]3
GELATININACTIVE INGREDIENT2G86QN327LLYRICA (PREGABALIN) CAPSULE [UNIT DOSE SERVICES]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLYRICA (PREGABALIN) CAPSULE [UNIT DOSE SERVICES]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLYRICA (PREGABALIN) CAPSULE [UNIT DOSE SERVICES]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LYRICA (PREGABALIN) CAPSULE [UNIT DOSE SERVICES]3
SHELLACINACTIVE INGREDIENT46N107B71OLYRICA (PREGABALIN) CAPSULE [UNIT DOSE SERVICES]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LYRICA (PREGABALIN) CAPSULE [UNIT DOSE SERVICES]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLYRICA (PREGABALIN) CAPSULE [UNIT DOSE SERVICES]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLYRICA (PREGABALIN) CAPSULE [UNIT DOSE SERVICES]3
TALCINACTIVE INGREDIENT7SEV7J4R1ULYRICA (PREGABALIN) CAPSULE [UNIT DOSE SERVICES]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLYRICA (PREGABALIN) CAPSULE [UNIT DOSE SERVICES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6523LYRICA (PREGABALIN) CAPSULE [UNIT DOSE SERVICES]8Legacy NDC, 3 package rows20190503_0c5d6728-be43-4e1b-9f14-a7ce920e12a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
607038Lyrica 75 MG Oral CapsulePSN0c5d6728-be43-4e1b-9f14-a7ce920e12a38
483450pregabalin 75 MG Oral CapsulePSN0c5d6728-be43-4e1b-9f14-a7ce920e12a38
607038pregabalin 75 MG Oral Capsule [Lyrica]SBD0c5d6728-be43-4e1b-9f14-a7ce920e12a38
483450pregabalin 75 MG Oral CapsuleSCD0c5d6728-be43-4e1b-9f14-a7ce920e12a38
607038Lyrica 75 MG Oral CapsuleSY0c5d6728-be43-4e1b-9f14-a7ce920e12a38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-6523-15043665230130 in 1 BOTTLEHistorical
50436-6523-25043665230260 in 1 BOTTLEHistorical
50436-6523-35043665230390 in 1 BOTTLEHistorical