FDA.reportPublic FDA data

NDC 54868-0451-0 - Premarin

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
54868-0451
Requested NDC
54868-0451-0
Package NDCs from labels
54868-0451-2, 54868-0451-6, 54868-0451-0
Manufacturer
Physicians Total Care, Inc.
Effective date
2014-05-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Premarin - Physicians Total Care, Inc.Physicians Total Care, Inc.2014-05-08HUMAN 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
54868-0451-22019-09-24C16284748780-19350213a-4223-c013-e053-90daa90a1393b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea
54868-0451-62019-09-24C16284748780-19350213a-4223-c013-e053-90daa90a1393b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-0451-2Premarin30 in 1 BOTTLETABLET, FILM COATED303
54868-0451-6Premarin10 in 1 BOTTLETABLET, FILM COATED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-0451PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]32 package rows20140512_b32fcb1b-fee4-44b8-a91c-10dfdd3f84ea.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-0451-0EA - Each54868-0451fb689e79-4c4d-448d-97fc-585101b3edb612012-07-24
54868-0451-1EA - Each54868-04517cfb461b-a1f5-4d71-9c9a-13c81fba43ae12012-07-24
54868-0451-2EA - Each54868-04515e5aec38-4849-41e0-afe3-65cde0179c8c12012-07-24
54868-0451-3EA - Each54868-045109563355-fbd0-40bf-87fd-89b32b1aeef812012-07-24
54868-0451-6EA - Each54868-045186dc37bd-52f0-4209-b23e-21513f04789c12012-07-24
54868-0451-7EA - Each54868-0451a7250132-3464-4fde-81b5-71ef325c6b9d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTROGENS, CONJUGATEDACTIVE INGREDIENTIU5QR144QXPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
ESTROGENS, CONJUGATEDACTIVE MOIETYIU5QR144QXPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3

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 15 of 120 · 2,399 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LigatoneARNICA MONTANA, BRYONIA, CALCAREA PHOSPHORICA, CAUSTICUM, KALI CARBONICUM, MANGANESE GLUCONATE, MEZEREUM, RHUS TOX, RUTA GRAVEOLENS, SILICEABioActive Nutritional, Inc.3a3bdd55-daec-43b9-a380-54a747fb7d102026-03-13WarningsExact identifier
unii: 91D9GV0Z28
Appetrol 20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Carbalor LLCd66234a3-2477-42be-8f7b-283e3a5f87ed2026-03-12WarningsExact identifier
unii: C151H8M554
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: B697894SGQ
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: B697894SGQ
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440CTITANIUM DIOXIDEKenvue Brands LLC4c335d9c-40ca-c0ce-e063-6394a90ac20a2026-03-11WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION4490f968-46b6-44d2-af2d-5130b52c88612026-03-05WarningsExact identifier
unii: 15FIX9V2JP
OsteoplexEQUISETUM HYEMALE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, MANGANUM MURIATICUM, SYMPHYTUM OFFICINALE, MEDULLA OSSIS SUIS, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA, PARATHYROID GLAND (SUIS), LIGAMENT (SUIS)BioActive Nutritional, Inc.8a7e1397-a387-4f2c-ab4f-7f1a7f1a849b2026-03-05WarningsExact identifier
unii: 91D9GV0Z28
Conjugated EstrogensESTROGENS, CONJUGATEDPrasco Laboratoriesce793f9e-0c20-43e6-9dc0-064e5c82e2432026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA004782
rxcui: 197660
rxcui: 197662
rxcui: 310197
rxcui: 403849
rxcui: 197661
unii: IU5QR144QX
TIBENA EVERY DAY REAL SUN BLOCKTITANIUM DIOXIDE, ZINC OXIDEKONAD CO LTD211c9930-4f91-cf8f-e063-6394a90a97b32026-02-26WarningsExact identifier
unii: 15FIX9V2JP
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION MATTE M B10TITANIUM DIOXIDEShiseido Americas Corporation54f8210f-4934-4ada-89c3-aa89e7a092602026-02-26WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORYOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc05cef12-a6a7-4682-9357-6d77f4ca32672026-02-25WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE RADIANT FOUNDATION N M I10OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation3be1fe06-bd3b-4078-bee9-d3caf8d068ff2026-02-25WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE THE FOUNDATION N M O20OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation9507f6d1-c11c-428d-8d95-b436f27ba26a2026-02-24WarningsExact identifier
unii: 15FIX9V2JP
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b93538a-3b3e-90f7-e063-6294a90ab8982026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b93cd22-1289-29bc-e063-6294a90ab7812026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b943d72-dcde-e2e4-e063-6294a90ab7c42026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING NON-TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b946c39-718b-d70e-e063-6394a90a0db82026-02-24WarningsExact identifier
unii: 15FIX9V2JP
BM BIO28 (General Tonic)CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited38d2cff0-3550-b119-e063-6394a90a31cb2026-02-23WarningsExact identifier
unii: 91D9GV0Z28
SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEShiseido Americas Corporationb93f10dc-193d-4cda-94b6-3f0e54d89f212026-02-23WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO ULTIMATE SUN PROTECTOR MINERALTITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION5e31eee8-6532-47ea-99fc-22418791804b2026-02-23WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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