FDA.reportPublic FDA data

NDC 54868-0451-3 - 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
54868-0451-3
Package NDCs from labels
54868-0451-2, 54868-0451-6, 54868-0451-3
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 55 of 120 · 2,399 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Sunscreen tintedTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3000a0a7-2b51-b832-e063-6294a90a4a082025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3001028b-bb36-04ec-e063-6294a90a1e492025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3001aa3a-cc8b-6ad4-e063-6394a90a223f2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC300268ff-f9ef-1006-e063-6294a90a5fdf2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Clear Path Tinted Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDELULUS SPA BOUTIQUE37657755-fa82-88a0-e063-6394a90ade472025-12-08Exact identifier
unii: 15FIX9V2JP
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare376468ce-8d9b-b672-e063-6294a90a0bd12025-12-08Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare37643884-f186-fb54-e063-6394a90a450f2025-12-08Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8208b-7328-1891-e063-6294a90abdd92025-12-08Exact identifier
unii: 15FIX9V2JP
Protect Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8dedc-0575-9819-e063-6394a90afebf2025-12-08Exact identifier
unii: 15FIX9V2JP
Protect Mineral Stick ClearTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bfa392-dfec-bd8a-e063-6394a90acffa2025-12-08Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b9d646-e049-6781-e063-6294a90ab1012025-12-08Exact identifier
unii: 15FIX9V2JP
Protect Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35c044a6-90be-55f8-e063-6294a90aad482025-12-08Exact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 27 MEDIUMOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247ed877-2926-1fd9-e063-6394a90aa1532025-12-08WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMELOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f1ad4c-af9a-c998-e063-6294a90a15db2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 31 TANOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f37a57-47ce-4175-e063-6394a90a92ee2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
RECHARGE Protect BlurTITANIUM DIOXIDE, ZINC OXIDERodan & Fields Beauty, LLCc787e3b9-33b1-4c47-95bd-b14cf65589382025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral Mist SPF-50TITANIUM DIOXIDE, ZINC OXIDETUBBY TODDdca54a19-af25-ce47-e053-2a95a90a22db2025-12-07WarningsExact identifier
unii: 15FIX9V2JP
Solbar Shield SPF40SOLBAR SHIELD SPF40Person and Coveybd3a9a94-fc87-4127-abf9-29e56ac9ce5d2025-12-04WarningsExact identifier
unii: 15FIX9V2JP
BM BIO28 ICING SUGARCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited3e855f3b-c73d-a153-e063-6394a90ad63a2025-12-02WarningsExact identifier
unii: 91D9GV0Z28
Bestmade Natural Products Bio28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro3e85a931-57f6-2a55-e063-6294a90ac1802025-12-02WarningsExact identifier
unii: 91D9GV0Z28

Reported adverse events (FAERS/openFDA)#

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