FDA.reportPublic FDA data

MethylTESTOSTERone

Product NDC
0115-1408
11-digit product format
001151408
Labeler code
0115
Product ID
0115-1408_12d97eee-36cf-470e-819a-02ec2218fb94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLTESTOSTERONE
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA204851
Marketing category
ANDA
Marketing start
2015-09-21
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0115-1408-012025-06-03C16284748780-11030e365-0db6-111a-e063-dadaa90a10e2Methyltestosterone Capsules, USP, CIII (10 mg) Rx only
0115-1408-032025-06-03C16284748780-11030e365-0db6-111a-e063-dadaa90a10e2Methyltestosterone Capsules, USP, CIII (10 mg) Rx only
0115-1408-082025-06-03C16284748780-11030e365-0db6-111a-e063-dadaa90a10e2Methyltestosterone Capsules, USP, CIII (10 mg) Rx only
0115-1408-012024-01-30C16284748780-11030e365-0db6-111a-e063-dadaa90a10e2Methyltestosterone Capsules, USP, CIII (10 mg) Rx only
0115-1408-032024-01-30C16284748780-11030e365-0db6-111a-e063-dadaa90a10e2Methyltestosterone Capsules, USP, CIII (10 mg) Rx only
0115-1408-082024-01-30C16284748780-11030e365-0db6-111a-e063-dadaa90a10e2Methyltestosterone Capsules, USP, CIII (10 mg) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1408-01MethylTESTOSTERone100 in 1 BOTTLECAPSULE10021
0115-1408-03MethylTESTOSTERone1000 in 1 BOTTLECAPSULE100021
0115-1408-08MethylTESTOSTERone30 in 1 BOTTLECAPSULE3021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1408-01EA - Each0115-140865da47a1-5196-4c04-b944-a24d2cd4690b12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLTESTOSTERONEACTIVE INGREDIENTV9EFU16ZIFMETHYLTESTOSTERONE CAPSULE [IMPAX GENERICS]10
METHYLTESTOSTERONEACTIVE MOIETYV9EFU16ZIFMETHYLTESTOSTERONE CAPSULE [IMPAX GENERICS]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMETHYLTESTOSTERONE CAPSULE [IMPAX GENERICS]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMETHYLTESTOSTERONE CAPSULE [IMPAX GENERICS]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETHYLTESTOSTERONE CAPSULE [IMPAX GENERICS]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMETHYLTESTOSTERONE CAPSULE [IMPAX GENERICS]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357METHYLTESTOSTERONE CAPSULE [IMPAX GENERICS]10
GELATININACTIVE INGREDIENT2G86QN327LMETHYLTESTOSTERONE CAPSULE [IMPAX GENERICS]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLTESTOSTERONE CAPSULE [IMPAX GENERICS]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METHYLTESTOSTERONE CAPSULE [IMPAX GENERICS]10
SHELLACINACTIVE INGREDIENT46N107B71OMETHYLTESTOSTERONE CAPSULE [IMPAX GENERICS]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHYLTESTOSTERONE CAPSULE [IMPAX GENERICS]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1408METHYLTESTOSTERONE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]19Current NDC, Legacy NDC, 3 package rows20201230_9bed4886-fcd0-4056-be8d-5bb4d15081ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197975methylTESTOSTERone 10 MG Oral CapsulePSN9bed4886-fcd0-4056-be8d-5bb4d15081ce21
197975methyltestosterone 10 MG Oral CapsuleSCD9bed4886-fcd0-4056-be8d-5bb4d15081ce21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1408-0100115140801100 CAPSULE in 1 BOTTLE (0115-1408-01) 100 capsule2015-09-210000-00-00NoNoCurrent
0115-1408-03001151408031000 CAPSULE in 1 BOTTLE (0115-1408-03) 1000 capsule2015-09-210000-00-00NoNoCurrent
0115-1408-080011514080830 CAPSULE in 1 BOTTLE (0115-1408-08) 30 capsule2015-09-210000-00-00NoNoCurrent