METHITEST

Product NDC
0115-7037
11-digit product format
001157037
Labeler code
0115
Product ID
0115-7037_d5da1ec5-4a9e-4714-9240-039f802b2c1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLTESTOSTERONE
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA080767
Marketing category
ANDA
Marketing start
1974-10-17
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
METHITEST
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLTESTOSTERONE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV9EFU16ZIF
Rxcui197976, 541524

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-7037-01METHITEST100 in 1 BOTTLETABLET10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-7037-01EA - Each0115-70371781622f-1b30-492d-acc3-fb032a256fed12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLTESTOSTERONEACTIVE INGREDIENTV9EFU16ZIFMETHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
METHYLTESTOSTERONEACTIVE MOIETYV9EFU16ZIFMETHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
ACACIAINACTIVE INGREDIENT5C5403N26OMETHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
GUAR GUMINACTIVE INGREDIENTE89I1637KEMETHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MMETHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
SUCROSEINACTIVE INGREDIENTC151H8M554METHITEST (METHYLTESTOSTERONE) TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-7037METHITEST (METHYLTESTOSTERONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]15Current NDC, Legacy NDC, 1 package rows20241022_77bb4ef4-c10e-4acc-8225-651d003f4561.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
541524METHITEST 10 MG Oral TabletPSN77bb4ef4-c10e-4acc-8225-651d003f456117
197976methylTESTOSTERone 10 MG Oral TabletPSN77bb4ef4-c10e-4acc-8225-651d003f456117
541524methyltestosterone 10 MG Oral Tablet [Methitest]SBD77bb4ef4-c10e-4acc-8225-651d003f456117
197976methyltestosterone 10 MG Oral TabletSCD77bb4ef4-c10e-4acc-8225-651d003f456117
541524Methitest 10 MG Oral TabletSY77bb4ef4-c10e-4acc-8225-651d003f456117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-7037-0100115703701100 TABLET in 1 BOTTLE (0115-7037-01) 100 tablet1974-10-170000-00-00NoNoCurrent