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 45 of 147 · 2,923 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
it cosmetics Your Skin But Better CC Plus Illumination Color Correcting Illuminating Broad Spectrum SPF 50 Plus Sunscreen Full Coverage FairLight NeutralTan RichHoney LightMedium and NeutralMediumTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCf493c3ea-41b3-4625-84a6-fab545a769402025-12-18WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC472f34c5-cefe-4884-9475-fd0666c925ac2025-12-18WarningsExact identifier
unii: 15FIX9V2JP
Vaccine Support CPBELLADONNA, CALCAREA CARBONICA, CARCINOSINUM, HYPERICUM PERFORATUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MALANDRINUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, PYROGENIUM, SARSAPARILLA, SILICEA, SULPHUR, THUJA OCCIDENTALISNatural Creations, Incb99f6b65-fe22-4dc2-97f8-8ab315396f752025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
SCROPHULOUS HPBARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, FERRUM IODATUM, MERCURIUS SOLUBILIS, PHYTOLACCA DECANDRA, RHUS TOX, SILICEABioActive Nutritional, Inc.3421f76b-bcde-42b5-a04b-05099520e6612025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
Sunscreen Lotion118mlZINC OXIDE 12%,TITANIUM DIOXIDE 6%, HOMOSALATE 14%,OCTISALATE 5%Foshan Sugar Max Cosmetics CO.,Ltd4620c41a-2188-00f5-e063-6394a90a613c2025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen CreamZINC OXIDE 15%,TITANIUM DIOXIDE 6%,HOMOSALATE 5%,OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46224dbe-a0fb-c242-e063-6394a90a26342025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Perricone High Potency Face Finishing and Firming MoisturizerTITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC2409cea1-7077-dc12-e063-6294a90a45582025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC3635a073-5484-f96c-e063-6394a90adef52025-12-17Exact identifier
unii: 15FIX9V2JP
Mineral Sunscreen LipTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC36362dc7-31d7-f766-e063-6294a90a129b2025-12-17Exact identifier
unii: 15FIX9V2JP
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski36480f7f-37e8-decd-e063-6394a90ada602025-12-17Exact identifier
unii: 15FIX9V2JP
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski364827bd-5781-eb53-e063-6394a90ab22f2025-12-17Exact identifier
unii: 15FIX9V2JP
non-tinted face mineral sunscreen SPF40TITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing3649bf1a-17c3-fe0b-e063-6294a90a13c02025-12-17Exact identifier
unii: 15FIX9V2JP
Tinted Mattifying Face Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing3649f634-8bcd-b3c1-e063-6394a90a49d92025-12-17Exact identifier
unii: 15FIX9V2JP
tinted lip mineral sunscreen SPF45TITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing364b023b-4a52-225a-e063-6394a90ad1972025-12-17Exact identifier
unii: 15FIX9V2JP
ULTAMATTE PROTECTION SUNSCREENTITANIUM DIOXIDE, ZINC OXIDESKINFINITY37efc466-17b8-9f7b-e063-6294a90a8c882025-12-17Exact identifier
unii: 15FIX9V2JP
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY MINDY LLC3cce3120-748e-a7fd-e063-6394a90a4d512025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY MINDY LLC3d5a2662-02e3-3a95-e063-6294a90a81202025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJKH Aesthetics LLC369ccb8f-d9b6-1fd2-e063-6394a90ace202025-12-17Exact identifier
unii: 15FIX9V2JP
Mattifying Mineral SPF40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d4f6a7-1115-1efa-e063-6294a90a20c42025-12-17Exact identifier
unii: 15FIX9V2JP
Mattifying Mineral SPF 40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d45700-fc41-ef54-e063-6394a90abcc32025-12-17Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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