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 53 of 120 · 2,399 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDERhonda J Pomerantz MD PLLC325cce54-a885-d586-e063-6394a90a90db2025-12-09Exact identifier
unii: 15FIX9V2JP
Sheer Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDETRU SKIN RITUALS324acd75-9c38-4adc-e063-6394a90afa122025-12-09Exact identifier
unii: 15FIX9V2JP
Foto Facial Age Delay Non-TintedTITANIUM DIOXIDE ZINC OXIDEADVANCED AESTHETIC DERMATOLOGY42674013-fa2b-42d7-e063-6294a90af9992025-12-09WarningsExact identifier
unii: 15FIX9V2JP
Foto Facial Age Delay Matte TintedTITANIUM DIOXIDE ZINC OXIDEADVANCED AESTHETIC DERMATOLOGY42761919-8ae2-3c41-e063-6394a90abb8f2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEYUMA ACNE CLINIC, L.L.C.3c69b707-07ff-1a82-e063-6394a90a9fcd2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEYUMA ACNE CLINIC, L.L.C.3c69f93f-0385-365c-e063-6394a90a12fd2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEASHLEY SAMAI38f457fa-0e95-7298-e063-6394a90adda82025-12-09Exact identifier
unii: 15FIX9V2JP
Tinted Primer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECECILIA EDWARDS36ea709b-3536-5052-e063-6394a90a48f92025-12-09Exact identifier
unii: 15FIX9V2JP
Age Defying Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDEMARK SCHWARTZ CLINICAL SKINCARE, INC.3b028159-f240-2cf2-e063-6294a90a32b52025-12-09WarningsExact identifier
unii: 15FIX9V2JP
G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREENZINC OXIDE, TITANIUM DIOXIDELABORATOIRES DERMO-COSMETIK INC.01dcfd14-7a1d-98fa-e063-6294a90a03362025-12-09WarningsExact identifier
unii: 15FIX9V2JP
Tinted Primer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECECILIA EDWARDS3aff2074-1514-b5c5-e063-6394a90a75722025-12-09Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER3729d270-64ac-4d2e-e063-6294a90aeb2c2025-12-09Exact identifier
unii: 15FIX9V2JP
Replenishing Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEBeauty Journey Studio LLC3738a0c3-5c07-e49b-e063-6394a90a38e92025-12-09Exact identifier
unii: 15FIX9V2JP
Replenishing Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEBeauty Journey Studio LLC37385fc6-1cde-8aa6-e063-6294a90a60172025-12-09Exact identifier
unii: 15FIX9V2JP
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3647f983-9e75-8955-e063-6294a90af1622025-12-08Exact identifier
unii: 15FIX9V2JP
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3649f758-e31b-3c6a-e063-6294a90a5c362025-12-08Exact identifier
unii: 15FIX9V2JP
Matte Shield SPFTITANIUM DIOXIDE, ZINC OXIDEACNE SOLUTIONS NYC INC3bb582ec-71e7-4ad8-e063-6394a90a94d42025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral Based Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245561d-a90c-7bf0-e063-6394a90ab3b62025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Based Sunscreen Stick TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245c1f7-2c1b-b6ad-e063-6394a90aaee62025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Based Foam Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION32465271-abb9-d03f-e063-6294a90a990e2025-12-08Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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