ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE

Product NDC
66576-284
11-digit product format
665760284
Labeler code
66576
Product ID
66576-284_ef483135-5654-cada-e053-2a95a90a9ec5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESTERIFIED ESTROGENS, METHYLTESTOSTERONE
Dosage form
TABLET
Route
ORAL
Labeler
Syntho Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-12-02
Marketing end
0000-00-00
Substance
ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE
Active strength
1 mg/1; mg/1
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9d0e3d5e-5fb0-9833-ff7c-640f05e449aeProduct name420230314
aaaf3f1f-0ca7-2c75-a463-4dc624538feeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66576-284-012024-01-30C16284748780-11030e365-57f4-111a-e063-dadaa90a10e2a75df5f3-b0a1-456c-97e8-0de506fe582f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66576-284-01ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66576-284ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE (ESTERIFIED ESTROGENS, METHYLTESTOSTERONE) TABLET [SYNTHO PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20221209_a75df5f3-b0a1-456c-97e8-0de506fe582f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238006estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral TabletPSNa75df5f3-b0a1-456c-97e8-0de506fe582f1
197670estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral TabletPSNa75df5f3-b0a1-456c-97e8-0de506fe582f1
238006estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral TabletSCDa75df5f3-b0a1-456c-97e8-0de506fe582f1
197670estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral TabletSCDa75df5f3-b0a1-456c-97e8-0de506fe582f1
197670EEMT DS Oral TabletSYa75df5f3-b0a1-456c-97e8-0de506fe582f1
238006EEMT HS Oral TabletSYa75df5f3-b0a1-456c-97e8-0de506fe582f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66576-284-0166576028401100 TABLET in 1 BOTTLE (66576-284-01) 100 tablet2022-12-020000-00-00NoNoCurrent