FDA.reportPublic FDA data

ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE

Product NDC
82619-136
11-digit product format
826190136
Labeler code
82619
Product ID
82619-136_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
.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
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ESTERIFIED ESTROGENS AND METHYLTESTOSTERONEESTERIFIED ESTROGENS AND METHYLTESTOSTERONECreekwood Pharmaceuticals LLC8e02dc79-c744-4e4a-81e9-4b050c40fbce2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 82619-136

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, ESTERIFIED.625 mg/1
METHYLTESTOSTERONE1.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V9EFU16ZIFInternal UNII lookup
3ASP8Q3768Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8e02dc79-c744-4e4a-81e9-4b050c40fbceAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82619-136-01ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE100 in 1 BOTTLETABLET1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238006estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral TabletPSN8e02dc79-c744-4e4a-81e9-4b050c40fbce1
197670estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral TabletPSN8e02dc79-c744-4e4a-81e9-4b050c40fbce1
238006estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral TabletSCD8e02dc79-c744-4e4a-81e9-4b050c40fbce1
197670estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral TabletSCD8e02dc79-c744-4e4a-81e9-4b050c40fbce1
197670EEMT DS Oral TabletSY8e02dc79-c744-4e4a-81e9-4b050c40fbce1
238006EEMT HS Oral TabletSY8e02dc79-c744-4e4a-81e9-4b050c40fbce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82619-136-0182619013601100 TABLET in 1 BOTTLE (82619-136-01) 100 tablet2026-01-12NoNoCurrent