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 50 of 147 · 2,923 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995f556-20fe-3e64-e063-6294a90a5efe2025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995385b-b10b-ca5c-e063-6294a90af43f2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3994aa84-30b4-3dc4-e063-6394a90a23e72025-12-15Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC39947913-f1cc-25d2-e063-6294a90a42292025-12-15Exact identifier
unii: 15FIX9V2JP
Solar Shield TintedTITANIUM DIOXIDE, ZINC OXIDEDENISE BELL SKIN CARE396eb781-5947-3665-e063-6294a90a38dd2025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC3542d8d3-35a3-7d63-e063-6394a90a6fd12025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer non-tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC354357de-1a85-3bdb-e063-6294a90aa9a22025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC35433254-1dc8-a8f3-e063-6394a90a29f02025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357eee3c-1c21-5efb-e063-6294a90a4bb72025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357e75ec-473e-df76-e063-6294a90a70c72025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f2f62-904a-2234-e063-6394a90aee722025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357ff025-84ad-6d77-e063-6394a90aad952025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY358021a2-235b-825b-e063-6394a90a76f52025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Physical DefenseTITANIUM DIOXIDE, ZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35477ed2-0875-58d5-e063-6294a90a3d5d2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35a97770-2db9-99aa-e063-6294a90a459a2025-12-15Exact identifier
unii: 15FIX9V2JP
Non-Tinted Sports StickTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35aa833a-19a1-99e9-e063-6394a90a840f2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Facial PrimerTITANIUM DIOXIDE, ZINC OXIDEBEE NATURALS36c3352e-fa51-19ad-e063-6394a90a591b2025-12-15Exact identifier
unii: 15FIX9V2JP
Velvet Tinted Moisturizing Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN BOSS L.L.C.35a871dc-a707-9963-e063-6294a90a43962025-12-15Exact identifier
unii: 15FIX9V2JP
Velvet NT Moisturizing Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN BOSS L.L.C.35a8508d-7069-c2d6-e063-6394a90a62192025-12-15Exact identifier
unii: 15FIX9V2JP
Proper Protection Plus Primer NTTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC3596fe93-836b-4f8e-e063-6294a90a674a2025-12-15Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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