FDA.reportPublic FDA data

Esterified Estrogens and Methyltestosterone

Product NDC
50220-001
11-digit product format
502200001
Labeler code
50220
Product ID
50220-001_b1baeda9-c804-4012-8932-6f5f3a7ca4e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esterified Estrogens and Methyltestosterone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Tal Pharma LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2010-09-17
Marketing end
0000-00-00
Substance
ESTRONE SODIUM SULFATE; METHYLTESTOSTERONE
Active strength
1 mg/1; mg/1
Pharmacologic classes
Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9d0e3d5e-5fb0-9833-ff7c-640f05e449aeProduct name420230314
16fd7d69-0da3-423a-f064-01fb62860837Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50220-001-012020-01-31C16284748780-19d75b9d0-5cc2-f424-e053-dadaa90a57cePhysician Labeling Esterified Estrogens and Methyltestosterone Tablets Full Strength and Half Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50220-001-01Esterified Estrogens and Methyltestosterone100 in 1 BOTTLETABLET, FILM COATED1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50220-001-01EA - Each50220-0019ddd3097-c4d8-46e8-ac21-72c8c04df49712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRONE SODIUM SULFATEACTIVE INGREDIENT6K6FDA543AESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET, FILM COATED [TAL PHARMA LLC]2
METHYLTESTOSTERONEACTIVE INGREDIENTV9EFU16ZIFESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET, FILM COATED [TAL PHARMA LLC]2
ESTRONEACTIVE MOIETY2DI9HA706AESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET, FILM COATED [TAL PHARMA LLC]2
METHYLTESTOSTERONEACTIVE MOIETYV9EFU16ZIFESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET, FILM COATED [TAL PHARMA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET, FILM COATED [TAL PHARMA LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET, FILM COATED [TAL PHARMA LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET, FILM COATED [TAL PHARMA LLC]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET, FILM COATED [TAL PHARMA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET, FILM COATED [TAL PHARMA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET, FILM COATED [TAL PHARMA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50220-001ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET, FILM COATED [TAL PHARMA LLC]2Legacy NDC, 1 package rows20101004_5845e789-8191-46f9-bbd0-79fb0c716601.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238006estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral TabletPSN5845e789-8191-46f9-bbd0-79fb0c7166012
238006estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral TabletSCD5845e789-8191-46f9-bbd0-79fb0c7166012
238006EEMT HS Oral TabletSY5845e789-8191-46f9-bbd0-79fb0c7166012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50220-001-0150220000101100 in 1 BOTTLEHistorical