Methyltestosterone

Product NDC
70954-255
11-digit product format
709540255
Labeler code
70954
Product ID
70954-255_987b3eb2-8e19-4ad6-bfdd-670b511d8dd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methyltestosterone
Dosage form
CAPSULE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA215270
Marketing category
ANDA
Marketing start
2022-02-18
Substance
METHYLTESTOSTERONE
Active strength
10 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
Methyltestosterone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLTESTOSTERONE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV9EFU16ZIF
Rxcui197975

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9d0e3d5e-5fb0-9833-ff7c-640f05e449aeProduct name420230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-255-10Methyltestosterone100 in 1 BOTTLECAPSULE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-255-10EA - Each70954-25598800152-3ecb-411f-afcc-d7ee8ab4e11712022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-255METHYLTESTOSTERONE CAPSULE [NOVITIUM PHARMA LLC]1Current NDC, Legacy NDC, 1 package rows20220223_c09c4cde-9f6c-4c4f-9d96-18beb5377564.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197975methylTESTOSTERone 10 MG Oral CapsulePSNc09c4cde-9f6c-4c4f-9d96-18beb53775642
197975methyltestosterone 10 MG Oral CapsuleSCDc09c4cde-9f6c-4c4f-9d96-18beb53775642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-255-1070954025510100 CAPSULE in 1 BOTTLE (70954-255-10) 100 capsule2022-02-180000-00-00NoNoCurrent