FDA.reportPublic FDA data

Lyrica

Product NDC
0071-1020
11-digit product format
000711020
Labeler code
0071
Product ID
0071-1020_b9b1285a-2cb3-4789-8b0e-8d5e1b253534
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
SOLUTION
Route
ORAL
Labeler
Parke-Davis Div of Pfizer Inc
Application
NDA022488
Marketing category
NDA
Marketing start
2010-01-04
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
20 mg/mL
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
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
0071-1020-01Lyrica473 mL in 1 BOTTLESOLUTION47359

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0071-1020-01ML - Milliliter0071-10208ff75d21-f59f-4761-b280-709c1b891a5f12013-02-13

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0071-1020LYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC]54Legacy 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0071-1020-0100071102001473 mL in 1 BOTTLE (0071-1020-01) 473 ml2010-01-040000-00-00NoNoCurrent