Esterified Estrogens and Methytestesterone

Product NDC
82619-104
11-digit product format
826190104
Labeler code
82619
Product ID
82619-104_aad630dd-24ec-4e93-981b-cca3ddfe29b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esterified Estrogens and Methytestesterone
Dosage form
TABLET
Route
ORAL
Labeler
Creekwood Pharmaceuticals LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-01-01
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9d0e3d5e-5fb0-9833-ff7c-640f05e449aeProduct name420230314
aaaf3f1f-0ca7-2c75-a463-4dc624538feeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82619-104-012024-01-30C16284748780-11030e365-5448-111a-e063-dadaa90a10e2Esterified Estrogens and Methyltestosterone Tablets Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82619-104-01Esterified Estrogens and Methytestesterone100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82619-104-01EA - Each82619-104b8bfb2b5-4e07-48ad-9f80-f8bacac7477812023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82619-104ESTERIFIED ESTROGENS AND METHYTESTESTERONE TABLET [CREEKWOOD PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20230101_710ec569-b90a-4f30-b66a-7bb6154c584f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238006estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral TabletPSN710ec569-b90a-4f30-b66a-7bb6154c584f1
197670estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral TabletPSN710ec569-b90a-4f30-b66a-7bb6154c584f1
238006estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral TabletSCD710ec569-b90a-4f30-b66a-7bb6154c584f1
197670estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral TabletSCD710ec569-b90a-4f30-b66a-7bb6154c584f1
197670EEMT DS Oral TabletSY710ec569-b90a-4f30-b66a-7bb6154c584f1
238006EEMT HS Oral TabletSY710ec569-b90a-4f30-b66a-7bb6154c584f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82619-104-0182619010401100 TABLET in 1 BOTTLE (82619-104-01) 100 tablet2023-01-010000-00-00NoNoCurrent