FDA.reportPublic FDA data

Esterified Estrogens and Methyltestosterone

Product NDC
62559-150
11-digit product format
625590150
Labeler code
62559
Product ID
62559-150_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
.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
Unii3ASP8Q3768, V9EFU16ZIF
Rxcui197670, 238006

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
9d0e3d5e-5fb0-9833-ff7c-640f05e449aeProduct name420230314
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-150-01Esterified Estrogens and Methyltestosterone100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-150-01EA - Each62559-1504e4ab836-6902-4cbb-86eb-31cebef21b8112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTROGENS, ESTERIFIEDACTIVE INGREDIENT3ASP8Q3768ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
METHYLTESTOSTERONEACTIVE INGREDIENTV9EFU16ZIFESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
ESTROGENS, ESTERIFIEDACTIVE MOIETY3ASP8Q3768ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
METHYLTESTOSTERONEACTIVE MOIETYV9EFU16ZIFESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
ACACIAINACTIVE INGREDIENT5C5403N26OESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
DIACETYLATED MONOGLYCERIDESINACTIVE INGREDIENT5Z17386USFESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
GELATININACTIVE INGREDIENT2G86QN327LESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
SHELLACINACTIVE INGREDIENT46N107B71OESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
SUCROSEINACTIVE INGREDIENTC151H8M554ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
TALCINACTIVE INGREDIENT7SEV7J4R1UESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANIP ACQUISITION COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-150ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE TABLET [ANI PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 1 package rows20241215_d42eeda8-d810-4481-a403-6a3520b9e69a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238006estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral TabletPSN39355c9a-509a-4918-8a9c-ae155950df3e103
238006estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral TabletPSNe01d5834-33ef-4583-8e45-e864e73c7ee5103
238006estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral TabletSCD39355c9a-509a-4918-8a9c-ae155950df3e103
238006estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral TabletSCDe01d5834-33ef-4583-8e45-e864e73c7ee5103
238006EEMT HS Oral TabletSY39355c9a-509a-4918-8a9c-ae155950df3e103
238006EEMT HS Oral TabletSYe01d5834-33ef-4583-8e45-e864e73c7ee5103
238006estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral TabletPSNfeeeca03-5c8c-4dae-878b-b96b2726179f100
238006estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral TabletSCDfeeeca03-5c8c-4dae-878b-b96b2726179f100
238006EEMT HS Oral TabletSYfeeeca03-5c8c-4dae-878b-b96b2726179f100
238006estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral TabletPSNd42eeda8-d810-4481-a403-6a3520b9e69a6
197670estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral TabletPSNd42eeda8-d810-4481-a403-6a3520b9e69a6
238006estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral TabletSCDd42eeda8-d810-4481-a403-6a3520b9e69a6
197670estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral TabletSCDd42eeda8-d810-4481-a403-6a3520b9e69a6
197670EEMT DS Oral TabletSYd42eeda8-d810-4481-a403-6a3520b9e69a6
238006EEMT HS Oral TabletSYd42eeda8-d810-4481-a403-6a3520b9e69a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-150-0162559015001100 TABLET in 1 BOTTLE (62559-150-01) 100 tablet2010-12-220000-00-00NoNoCurrent