FDA.reportPublic FDA data

Lyrica

Product NDC
0071-1019
11-digit product format
000711019
Labeler code
0071
Product ID
0071-1019_e7c79058-03ba-4e7f-9a31-9ec5ce245161
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Parke-Davis Div of Pfizer Inc
Application
NDA021446
Marketing category
NDA
Marketing start
2004-12-30
Marketing end
2026-05-31
Substance
PREGABALIN
Active strength
225 mg/1
DEA schedule
CV
NDC exclude flag
No
Current FDA listing
Yes

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
0071-1019-68Lyrica90 in 1 BOTTLECAPSULE9059

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0071-1019-68EA - Each0071-10192e2aeb3a-97f2-420e-b04f-8e425708fc5a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREGABALINACTIVE INGREDIENT55JG375S6MLYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
PREGABALINACTIVE MOIETY55JG375S6MLYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
GELATININACTIVE INGREDIENT2G86QN327LLYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
SHELLACINACTIVE INGREDIENT46N107B71OLYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FLYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4LYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
TALCINACTIVE INGREDIENT7SEV7J4R1ULYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
WATERINACTIVE INGREDIENT059QF0KO0RLYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]22
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
0071-1019LYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]54Current NDC, Legacy NDC, 1 package rows20250510_60185c88-ecfd-46f9-adb9-b97c6b00a553.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
607018Lyrica 100 MG Oral CapsulePSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
607020Lyrica 150 MG Oral CapsulePSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
898718Lyrica 20 MG in 1 mL Oral SolutionPSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
607022Lyrica 200 MG Oral CapsulePSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
607024Lyrica 225 MG Oral CapsulePSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
607026Lyrica 25 MG Oral CapsulePSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
607028Lyrica 300 MG Oral CapsulePSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
607033Lyrica 50 MG Oral CapsulePSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
607038Lyrica 75 MG Oral CapsulePSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
483438pregabalin 100 MG Oral CapsulePSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
483440pregabalin 150 MG Oral CapsulePSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
898715pregabalin 20 MG in 1 mL Oral SolutionPSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
483446pregabalin 200 MG Oral CapsulePSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
577127pregabalin 225 MG Oral CapsulePSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
483442pregabalin 25 MG Oral CapsulePSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
483444pregabalin 300 MG Oral CapsulePSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
483448pregabalin 50 MG Oral CapsulePSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
483450pregabalin 75 MG Oral CapsulePSN60185c88-ecfd-46f9-adb9-b97c6b00a55359
607018pregabalin 100 MG Oral Capsule [Lyrica]SBD60185c88-ecfd-46f9-adb9-b97c6b00a55359
607020pregabalin 150 MG Oral Capsule [Lyrica]SBD60185c88-ecfd-46f9-adb9-b97c6b00a55359
898718pregabalin 20 MG/ML Oral Solution [Lyrica]SBD60185c88-ecfd-46f9-adb9-b97c6b00a55359
607022pregabalin 200 MG Oral Capsule [Lyrica]SBD60185c88-ecfd-46f9-adb9-b97c6b00a55359
607024pregabalin 225 MG Oral Capsule [Lyrica]SBD60185c88-ecfd-46f9-adb9-b97c6b00a55359
607026pregabalin 25 MG Oral Capsule [Lyrica]SBD60185c88-ecfd-46f9-adb9-b97c6b00a55359
607028pregabalin 300 MG Oral Capsule [Lyrica]SBD60185c88-ecfd-46f9-adb9-b97c6b00a55359
607033pregabalin 50 MG Oral Capsule [Lyrica]SBD60185c88-ecfd-46f9-adb9-b97c6b00a55359
607038pregabalin 75 MG Oral Capsule [Lyrica]SBD60185c88-ecfd-46f9-adb9-b97c6b00a55359
483438pregabalin 100 MG Oral CapsuleSCD60185c88-ecfd-46f9-adb9-b97c6b00a55359
483440pregabalin 150 MG Oral CapsuleSCD60185c88-ecfd-46f9-adb9-b97c6b00a55359
898715pregabalin 20 MG/ML Oral SolutionSCD60185c88-ecfd-46f9-adb9-b97c6b00a55359
483446pregabalin 200 MG Oral CapsuleSCD60185c88-ecfd-46f9-adb9-b97c6b00a55359
577127pregabalin 225 MG Oral CapsuleSCD60185c88-ecfd-46f9-adb9-b97c6b00a55359
483442pregabalin 25 MG Oral CapsuleSCD60185c88-ecfd-46f9-adb9-b97c6b00a55359
483444pregabalin 300 MG Oral CapsuleSCD60185c88-ecfd-46f9-adb9-b97c6b00a55359
483448pregabalin 50 MG Oral CapsuleSCD60185c88-ecfd-46f9-adb9-b97c6b00a55359
483450pregabalin 75 MG Oral CapsuleSCD60185c88-ecfd-46f9-adb9-b97c6b00a55359
607018Lyrica 100 MG Oral CapsuleSY60185c88-ecfd-46f9-adb9-b97c6b00a55359
607020Lyrica 150 MG Oral CapsuleSY60185c88-ecfd-46f9-adb9-b97c6b00a55359
898718Lyrica 20 MG per 1 ML Oral SolutionSY60185c88-ecfd-46f9-adb9-b97c6b00a55359
898718Lyrica 20 MG/ML Oral SolutionSY60185c88-ecfd-46f9-adb9-b97c6b00a55359
607022Lyrica 200 MG Oral CapsuleSY60185c88-ecfd-46f9-adb9-b97c6b00a55359
607024Lyrica 225 MG Oral CapsuleSY60185c88-ecfd-46f9-adb9-b97c6b00a55359
607026Lyrica 25 MG Oral CapsuleSY60185c88-ecfd-46f9-adb9-b97c6b00a55359
607028Lyrica 300 MG Oral CapsuleSY60185c88-ecfd-46f9-adb9-b97c6b00a55359
607033Lyrica 50 MG Oral CapsuleSY60185c88-ecfd-46f9-adb9-b97c6b00a55359
607038Lyrica 75 MG Oral CapsuleSY60185c88-ecfd-46f9-adb9-b97c6b00a55359
898715pregabalin 20 MG per 1 ML Oral SolutionSY60185c88-ecfd-46f9-adb9-b97c6b00a55359
607024Lyrica 225 MG Oral CapsulePSNaac6c6a4-17a3-4643-bc89-db7259aca03a1
577127pregabalin 225 MG Oral CapsulePSNaac6c6a4-17a3-4643-bc89-db7259aca03a1
607024pregabalin 225 MG Oral Capsule [Lyrica]SBDaac6c6a4-17a3-4643-bc89-db7259aca03a1
577127pregabalin 225 MG Oral CapsuleSCDaac6c6a4-17a3-4643-bc89-db7259aca03a1
607024Lyrica 225 MG Oral CapsuleSYaac6c6a4-17a3-4643-bc89-db7259aca03a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0071-1019-680007110196890 CAPSULE in 1 BOTTLE (0071-1019-68) 90 capsule2004-12-302026-05-31NoNoCurrent