FDA.reportPublic FDA data

EEMT

Product NDC
15310-010
Requested package NDC
15310-010-01
11-digit product format
153100010
Labeler code
15310
Product ID
15310-010_9cbda496-ef2b-18af-e053-2995a90a2321
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESTROGENS, ESTERIFIED and METHYLTESTOSTERONE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CREEKWOOD PHARMACEUTICAL, INC,
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-09-01
Marketing end
0000-00-00
Substance
METHYLTESTOSTERONE; ESTROGENS, ESTERIFIED
Active strength
3 mg/1; mg/1
Pharmacologic classes
Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage15310-01015310-010-01IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
aaaf3f1f-0ca7-2c75-a463-4dc624538feeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15310-010-012022-01-28C16284748780-1d6a99b39-edfe-a426-e053-dadaa90af4c2Physician Labeling ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15310-010-01EEMT100 in 1 BOTTLE, PLASTICTABLET, COATED1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15310-010-01EA - Each15310-0101101602f-04c7-4bff-a899-a1c9f41eb56012013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTROGENS, ESTERIFIEDACTIVE INGREDIENT3ASP8Q3768EEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1
METHYLTESTOSTERONEACTIVE INGREDIENTV9EFU16ZIFEEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1
ESTROGENS, ESTERIFIEDACTIVE MOIETY3ASP8Q3768EEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1
METHYLTESTOSTERONEACTIVE MOIETYV9EFU16ZIFEEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933EEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKEEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GEEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990EEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOEEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULREEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1
TALCINACTIVE INGREDIENT7SEV7J4R1UEEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15310-010EEMT HS (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED EEMT (ESTROGENS, ESTERIFIED AND METHYLTESTOSTERONE) TABLET, COATED [CREEKWOOD PHARMACEUTICAL, INC,]2Legacy NDC, 1 package rows20200126_1db7b3c7-14e3-43ef-b519-e2b880edbd5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238006estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral TabletPSN1db7b3c7-14e3-43ef-b519-e2b880edbd5b2
197670estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral TabletPSN1db7b3c7-14e3-43ef-b519-e2b880edbd5b2
238006estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral TabletSCD1db7b3c7-14e3-43ef-b519-e2b880edbd5b2
197670estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral TabletSCD1db7b3c7-14e3-43ef-b519-e2b880edbd5b2
197670EEMT DS Oral TabletSY1db7b3c7-14e3-43ef-b519-e2b880edbd5b2
238006EEMT HS Oral TabletSY1db7b3c7-14e3-43ef-b519-e2b880edbd5b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
15310-010-0115310001001100 TABLET, COATED in 1 BOTTLE, PLASTIC (15310-010-01) 2011-09-010000-00-00NoNoCurrent