FDA.reportPublic FDA data

NDC 54868-5494-2 - Lyrica

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
54868-5494
Requested NDC
54868-5494-2
Package NDCs from labels
54868-5494-0, 54868-5494-1, 54868-5494-2
Manufacturer
Physicians Total Care, Inc.
Effective date
2014-02-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lyrica - Physicians Total Care, Inc.Physicians Total Care, Inc.2014-02-14HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54868-5494-02019-09-24C16284748780-19350213a-48fb-c013-e053-90daa90a1393These 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
54868-5494-12019-09-24C16284748780-19350213a-48fb-c013-e053-90daa90a1393These 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
54868-5494-0Lyrica90 in 1 BOTTLECAPSULE904
54868-5494-1Lyrica30 in 1 BOTTLECAPSULE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-5494LYRICA (PREGABALIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]42 package rows20140218_3e1fb774-7460-44d2-bf96-a17c59999676.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-5494-0EA - Each54868-549454535615-43df-47a6-a5b8-754dcacc915912012-07-24
54868-5494-1EA - Each54868-5494c3b56869-e6a5-4fd3-b73d-7a0b42e8d5a112012-07-24
54868-5494-2EA - Each54868-54945be84935-0f65-4145-b6db-8d1ca7619cb512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREGABALINACTIVE INGREDIENT55JG375S6MLYRICA (PREGABALIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
PREGABALINACTIVE MOIETY55JG375S6MLYRICA (PREGABALIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LYRICA (PREGABALIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LYRICA (PREGABALIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
GELATININACTIVE INGREDIENT2G86QN327LLYRICA (PREGABALIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLYRICA (PREGABALIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLYRICA (PREGABALIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LYRICA (PREGABALIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OLYRICA (PREGABALIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LYRICA (PREGABALIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLYRICA (PREGABALIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLYRICA (PREGABALIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1ULYRICA (PREGABALIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLYRICA (PREGABALIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 36 of 147 · 2,938 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 Fair ShirakabaOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION26151cf4-0fee-4a42-92fd-4d7b9cef83812026-01-06WarningsExact identifier
unii: 15FIX9V2JP
Drs. pharmacy sunscreen SPF 50 (physical filters)SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)315a5ca4-4536-d585-e063-6294a90a1c502026-01-06WarningsExact identifier
unii: 15FIX9V2JP
Drs. pharmacy sunscreen SPF 30 (Physical Filters)SUNSCREEN SPF 30OL PHARMA TECH LLC. (Drs. Pharmacy)315a5b1f-9dc2-a243-e063-6394a90a5e082026-01-06WarningsExact identifier
unii: 15FIX9V2JP
PREGABALINPREGABALINMajor Pharmaceuticals2420e2d7-c01a-4590-88c5-6fe5361747e92026-01-06Warnings, Adverse reactionsExact identifier
rxcui: 483440
rxcui: 483442
rxcui: 483448
rxcui: 483438
rxcui: 483450
rxcui: 483446
unii: 55JG375S6M
LING NEW YORK Save Face Broad Spectrum SPF 30LING NEW YORK SAVE FACE BROAD SPECTRUM SPF 30Guangzhou Fantesy Biotechnology Co.,Ltd1dfa80bd-495a-18fb-e063-6394a90a4d0d2026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION236bdb53-d7a5-43a2-8a0c-bce4a5522e262026-01-05WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE RADIANT FOUNDATION N I10OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION05ffb157-5e28-4e94-866d-9e3371480d842026-01-05WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE CONCEALER N 1TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONeedf8065-8897-4773-9cbb-bab57d2dd04f2026-01-05WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE BRIGHTENING ENHANCER VEILOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbb00d6d7-cc51-4fee-a0df-68bbd5bc50d62026-01-05WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbeefe840-6f32-483b-8a37-2696adb8eea12026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO SPORTS BB LIGHTOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION260a3eab-8fe6-4259-8dcc-3706ca1f68812026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATIONc656792a-e1ed-478d-b501-9bdc92d16eca2026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 110 ALABASTEROCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION0a214b6b-69a7-4cb9-9095-6fcf2b6945de2026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAROCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONfb6ac681-ff74-4420-a4f6-843d5f2b6d6b2026-01-05WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Blend Essential Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group47aa8605-e536-b998-e063-6394a90ad9f02026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHTOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbf736c5b-fc33-4cd5-8d18-03929f739d762026-01-05WarningsExact identifier
unii: 15FIX9V2JP
CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc4028089-677f-4d51-9c8b-3892ff1649e02026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION8a0da327-a805-4ef9-b69a-14bf7278a81a2026-01-05WarningsExact identifier
unii: 15FIX9V2JP
CLE DE PEAU BEAUTE CORRECTING VEIL nENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONfd9b42e4-6f9d-45a9-bee3-ac1bc4b352522026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO THE MAKEUP FOUNDATION I20TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION3c024fe9-2983-4857-a55a-13406158e3a92026-01-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.