FDA.reportPublic FDA data

Lyrica

Product NDC
21695-664
11-digit product format
216950664
Labeler code
21695
Product ID
21695-664_8fb45a78-b2d8-45dd-b844-0de21d1fdde9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021446
Marketing category
NDA
Marketing start
2004-12-30
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
300 mg/1
DEA schedule
CV
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-664-902019-09-24C16284748780-1934fe258-47f7-48b1-e053-8cdaa90a720aThese 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
21695-664-90Lyrica90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-664-90EA - Each21695-66464129303-8848-4844-853a-b5343562d45b12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-664LYRICA (PREGABALIN) CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110622_8fb45a78-b2d8-45dd-b844-0de21d1fdde9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
607018Lyrica 100 MG Oral CapsulePSN8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607020Lyrica 150 MG Oral CapsulePSN8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607022Lyrica 200 MG Oral CapsulePSN8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607026Lyrica 25 MG Oral CapsulePSN8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607028Lyrica 300 MG Oral CapsulePSN8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607033Lyrica 50 MG Oral CapsulePSN8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607038Lyrica 75 MG Oral CapsulePSN8fb45a78-b2d8-45dd-b844-0de21d1fdde91
483438pregabalin 100 MG Oral CapsulePSN8fb45a78-b2d8-45dd-b844-0de21d1fdde91
483440pregabalin 150 MG Oral CapsulePSN8fb45a78-b2d8-45dd-b844-0de21d1fdde91
483446pregabalin 200 MG Oral CapsulePSN8fb45a78-b2d8-45dd-b844-0de21d1fdde91
483442pregabalin 25 MG Oral CapsulePSN8fb45a78-b2d8-45dd-b844-0de21d1fdde91
483444pregabalin 300 MG Oral CapsulePSN8fb45a78-b2d8-45dd-b844-0de21d1fdde91
483448pregabalin 50 MG Oral CapsulePSN8fb45a78-b2d8-45dd-b844-0de21d1fdde91
483450pregabalin 75 MG Oral CapsulePSN8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607018pregabalin 100 MG Oral Capsule [Lyrica]SBD8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607020pregabalin 150 MG Oral Capsule [Lyrica]SBD8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607022pregabalin 200 MG Oral Capsule [Lyrica]SBD8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607026pregabalin 25 MG Oral Capsule [Lyrica]SBD8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607028pregabalin 300 MG Oral Capsule [Lyrica]SBD8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607033pregabalin 50 MG Oral Capsule [Lyrica]SBD8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607038pregabalin 75 MG Oral Capsule [Lyrica]SBD8fb45a78-b2d8-45dd-b844-0de21d1fdde91
483438pregabalin 100 MG Oral CapsuleSCD8fb45a78-b2d8-45dd-b844-0de21d1fdde91
483440pregabalin 150 MG Oral CapsuleSCD8fb45a78-b2d8-45dd-b844-0de21d1fdde91
483446pregabalin 200 MG Oral CapsuleSCD8fb45a78-b2d8-45dd-b844-0de21d1fdde91
483442pregabalin 25 MG Oral CapsuleSCD8fb45a78-b2d8-45dd-b844-0de21d1fdde91
483444pregabalin 300 MG Oral CapsuleSCD8fb45a78-b2d8-45dd-b844-0de21d1fdde91
483448pregabalin 50 MG Oral CapsuleSCD8fb45a78-b2d8-45dd-b844-0de21d1fdde91
483450pregabalin 75 MG Oral CapsuleSCD8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607018Lyrica 100 MG Oral CapsuleSY8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607020Lyrica 150 MG Oral CapsuleSY8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607022Lyrica 200 MG Oral CapsuleSY8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607026Lyrica 25 MG Oral CapsuleSY8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607028Lyrica 300 MG Oral CapsuleSY8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607033Lyrica 50 MG Oral CapsuleSY8fb45a78-b2d8-45dd-b844-0de21d1fdde91
607038Lyrica 75 MG Oral CapsuleSY8fb45a78-b2d8-45dd-b844-0de21d1fdde91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-664-902169506649090 in 1 BOTTLEHistorical