FDA.reportPublic FDA data

Esterified Estrogens and Methyltestosterone

Product NDC
51293-639
11-digit product format
512930639
Labeler code
51293
Product ID
51293-639_472dd7a9-5939-e41e-e063-6294a90ab608
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esterified Estrogens and Methyltestosterone
Dosage form
TABLET
Route
ORAL
Labeler
ECI Pharmaceuticals LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-12-15
Substance
ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE
Active strength
.625; 1.25 mg/1; mg/1
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Esterified Estrogens and Methyltestosterone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTROGENS, ESTERIFIED.625 mg/1
METHYLTESTOSTERONE1.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV9EFU16ZIF, 3ASP8Q3768
Rxcui197670, 238006

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9d0e3d5e-5fb0-9833-ff7c-640f05e449aeProduct name420230314
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
aaaf3f1f-0ca7-2c75-a463-4dc624538feeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51293-639-012025-12-30C16284748780-11030e365-2a89-111a-e063-dadaa90a10e2Esterified Estrogens and Methyltestosterone Tablets Rx Only
51293-639-012024-01-30C16284748780-11030e365-2a89-111a-e063-dadaa90a10e2Esterified Estrogens and Methyltestosterone Tablets Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51293-639-01Esterified Estrogens and Methyltestosterone100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51293-639-01EA - Each51293-639fae1f1a8-6f03-45ad-9e4c-15968bfe8f3612021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51293-639ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ECI PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 1 package rows20220311_ad741c46-8c9d-4880-bc8b-304132baa8dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238006estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral TabletPSN2157d248-f6f5-4cb4-806d-d2e8eec6a8db103
238006estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral TabletSCD2157d248-f6f5-4cb4-806d-d2e8eec6a8db103
238006EEMT HS Oral TabletSY2157d248-f6f5-4cb4-806d-d2e8eec6a8db103
238006estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral TabletPSNad741c46-8c9d-4880-bc8b-304132baa8dc3
197670estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral TabletPSNad741c46-8c9d-4880-bc8b-304132baa8dc3
238006estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral TabletSCDad741c46-8c9d-4880-bc8b-304132baa8dc3
197670estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral TabletSCDad741c46-8c9d-4880-bc8b-304132baa8dc3
197670EEMT DS Oral TabletSYad741c46-8c9d-4880-bc8b-304132baa8dc3
238006EEMT HS Oral TabletSYad741c46-8c9d-4880-bc8b-304132baa8dc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51293-639-0151293063901100 TABLET in 1 BOTTLE (51293-639-01) 100 tablet2020-12-150000-00-00NoNoCurrent