Esterified Estrogens and Methyltestosterone

Product NDC: 62559-149
11-digit product format: 625590149
Labeler code: 62559
Product ID: 62559-149_027e7148-2471-49b5-9fea-88d7c2d7684c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esterified Estrogens and Methyltestosterone
Dosage form: TABLET
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2010-12-22
Substance: ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE
Active strength: 1.25; 2.5 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

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTROGENS, ESTERIFIED	1.25 mg/1
METHYLTESTOSTERONE	2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3ASP8Q3768	Internal UNII lookup
V9EFU16ZIF	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197670	Internal RxNorm lookup
238006	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d42eeda8-d810-4481-a403-6a3520b9e69a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
9d0e3d5e-5fb0-9833-ff7c-640f05e449ae	Product name	4	20230314
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
aaaf3f1f-0ca7-2c75-a463-4dc624538fee	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62559-149-01	Esterified Estrogens and Methyltestosterone	100 in 1 BOTTLE	TABLET	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62559-149-01	EA - Each	62559-149	be9be45b-6444-4dda-9f9a-261799e4b95e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESTROGENS, ESTERIFIED	ACTIVE INGREDIENT	3ASP8Q3768	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
METHYLTESTOSTERONE	ACTIVE INGREDIENT	V9EFU16ZIF	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
ESTROGENS, ESTERIFIED	ACTIVE MOIETY	3ASP8Q3768	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
METHYLTESTOSTERONE	ACTIVE MOIETY	V9EFU16ZIF	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
ACACIA	INACTIVE INGREDIENT	5C5403N26O	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
DIACETYLATED MONOGLYCERIDES	INACTIVE INGREDIENT	5Z17386USF	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62559-149	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANI PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20241215_d42eeda8-d810-4481-a403-6a3520b9e69a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esterified Estrogens and Methyltestosterone	ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE	ANI Pharmaceuticals, Inc.	d42eeda8-d810-4481-a403-6a3520b9e69a	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 62559-149

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
197670	estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral Tablet	PSN	e5b1ce1a-b1dd-47ce-9602-9f8d51ac94da	104
197670	estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral Tablet	SCD	e5b1ce1a-b1dd-47ce-9602-9f8d51ac94da	104
197670	EEMT DS Oral Tablet	SY	e5b1ce1a-b1dd-47ce-9602-9f8d51ac94da	104
197670	estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral Tablet	PSN	759907a1-2da7-47df-bf7f-e642f60b998f	103
197670	estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral Tablet	SCD	759907a1-2da7-47df-bf7f-e642f60b998f	103
197670	EEMT DS Oral Tablet	SY	759907a1-2da7-47df-bf7f-e642f60b998f	103
238006	estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral Tablet	PSN	d42eeda8-d810-4481-a403-6a3520b9e69a	6
197670	estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral Tablet	PSN	d42eeda8-d810-4481-a403-6a3520b9e69a	6
238006	estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral Tablet	SCD	d42eeda8-d810-4481-a403-6a3520b9e69a	6
197670	estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral Tablet	SCD	d42eeda8-d810-4481-a403-6a3520b9e69a	6
197670	EEMT DS Oral Tablet	SY	d42eeda8-d810-4481-a403-6a3520b9e69a	6
238006	EEMT HS Oral Tablet	SY	d42eeda8-d810-4481-a403-6a3520b9e69a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62559-149-01	62559014901	100 TABLET in 1 BOTTLE (62559-149-01)	100 tablet	2010-12-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Esterified Estrogens and Methyltestosterone	Bryant Ranch Prepack	2026-02-26	HUMAN PRESCRIPTION DRUG LABEL	103
Esterified Estrogens and Methyltestosterone	ANI Pharmaceuticals, Inc.	2025-09-12	HUMAN PRESCRIPTION DRUG LABEL	6
Esterified Estrogens and Methyltestosterone	Bryant Ranch Prepack	2025-02-10	HUMAN PRESCRIPTION DRUG LABEL	104