ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE

Product NDC
82619-137
11-digit product format
826190137
Labeler code
82619
Product ID
82619-137_47dd4dbc-52db-bd45-e063-6294a90a5fca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
esterified estrogens and methyltestosterone
Dosage form
TABLET
Route
ORAL
Labeler
Creekwood Pharmaceuticals LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-01-12
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTROGENS, ESTERIFIED1.25 mg/1
METHYLTESTOSTERONE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3ASP8Q3768, V9EFU16ZIF
Rxcui197670, 238006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82619-137-01ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE100 in 1 BOTTLETABLET1001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82619-137-0182619013701100 TABLET in 1 BOTTLE (82619-137-01) 100 tablet2026-01-12NoNoHistorical