ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE

Product NDC: 66576-283
11-digit product format: 665760283
Labeler code: 66576
Product ID: 66576-283_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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66576-283		I	Inactivated by FDA		2026-10-05
excluded package	package	66576-283	66576-283-01	I	Inactivated by FDA		2026-10-05

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66576-283-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66576-283-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66576-283-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66576-283-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66576-283-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66576-283-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66576-283-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66576-283-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66576-283-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66576-283-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66576-283-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66576-283-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66576-283-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66576-283-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66576-283-01	`1332a3947898…`	`d4bfe170f9cd…`

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 concept	Relation	Version	Effective
9d0e3d5e-5fb0-9833-ff7c-640f05e449ae	Product name	4	20230314
aaaf3f1f-0ca7-2c75-a463-4dc624538fee	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66576-283-01	2024-01-30	C162847	48780-1	1030e365-57f4-111a-e063-dadaa90a10e2	a75df5f3-b0a1-456c-97e8-0de506fe582f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66576-283-01	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE	100 in 1 BOTTLE	TABLET	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66576-283	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE (ESTERIFIED ESTROGENS, METHYLTESTOSTERONE) TABLET [SYNTHO PHARMACEUTICALS, INC.]	1	Legacy NDC, 1 package rows	20221209_a75df5f3-b0a1-456c-97e8-0de506fe582f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3ASP8Q3768	ESTROGENS, ESTERIFIED		ESTROGENS, ESTERIFIED
V9EFU16ZIF	METHYLTESTOSTERONE	58-18-4	METHYLTESTOSTERONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238006	estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral Tablet	PSN	a75df5f3-b0a1-456c-97e8-0de506fe582f	1
197670	estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral Tablet	PSN	a75df5f3-b0a1-456c-97e8-0de506fe582f	1
238006	estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral Tablet	SCD	a75df5f3-b0a1-456c-97e8-0de506fe582f	1
197670	estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral Tablet	SCD	a75df5f3-b0a1-456c-97e8-0de506fe582f	1
197670	EEMT DS Oral Tablet	SY	a75df5f3-b0a1-456c-97e8-0de506fe582f	1
238006	EEMT HS Oral Tablet	SY	a75df5f3-b0a1-456c-97e8-0de506fe582f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66576-283-01	66576028301	100 TABLET in 1 BOTTLE (66576-283-01)	100 tablet	2022-12-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE - Syntho Pharmaceuticals, Inc.	Syntho Pharmaceuticals, Inc.	2022-12-07	HUMAN PRESCRIPTION DRUG LABEL	1