FDA.reportPublic FDA data

Testone CIK

Product NDC
76420-650
Requested package NDC
76420-650-01
11-digit product format
764200650
Labeler code
76420
Product ID
76420-650_23e81cde-1d04-4e23-ba5c-97f6e1e08495
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone Cypionate, Alcohol
Dosage form
KIT
Labeler
Asclemed USA, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2007-12-21
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage76420-65076420-650-01DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Testone CIK
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
835840Internal RxNorm lookup
2047882Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
edcd5209-70db-4727-991e-3fdd185d9211Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2db4fc38-a116-b0ab-3dae-57df54e5f212Product name220250121
386d1b2a-e9b7-0c83-111f-2a77b92895b3Product name520240422
7d55b53c-798b-47ae-992b-3921493a8303Product name120230322
8d753fd6-75b2-4f12-bcbf-339392960afaProduct name120230303
4fbda828-a5be-46fe-83ec-a88da4359919Product name120230104
93cc9bee-8bdc-273d-ec7f-c2c52535317aProduct name720210902
a6389cd1-36d1-4b5c-9934-1139bee93605Product name520210601
f4f0889f-ee8b-471f-9a37-02a035280637Product name120200122
09e1afd3-f431-4380-82c5-438884c25615Product name120190111
a6389cd1-36d1-4b5c-9934-1139bee93605Product name320171212
502efed8-01a5-ef6a-61c6-fe8302b6e26bProduct name220171113
8b700cfd-17dd-41a2-90f5-a80ae8a989a2Product name120171113
9ce0e503-4ae7-2c6a-39ae-85285c29db68Product name220171113
96bdf4b3-71cd-433d-9723-89e50f852992Product name120150810
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0574-0820-01Testone CIK1 in 1 CARTONINJECTION, SOLUTION200 mg in 1mL11
0574-0820-01Testone CIK1 mL in 1 VIAL, GLASSINJECTION, SOLUTION1 mL200 mg in 1mL11
76420-650-01Testone CIK1 in 1 CARTONKIT111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-650-01EA - Each76420-65004cb2dfa-d5a9-4bd2-a88b-47c39148715812015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Isopropyl AlcoholACTIVE INGREDIENTND2M416302TESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]1
Testosterone CypionateACTIVE INGREDIENTM0XW1UBI14TESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]1
Isopropyl AlcoholACTIVE MOIETYND2M416302TESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]1
TestosteroneACTIVE MOIETY3XMK78S47OTESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]1
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHTESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]1
Benzyl BenzoateINACTIVE INGREDIENTN863NB338GTESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]1
Cottonseed OilINACTIVE INGREDIENTH3E878020NTESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RTESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-650TESTONE CIK (TESTOSTERONE CYPIONATE, ALCOHOL) KIT [ASCLEMED USA, INC.]10Current NDC, Legacy NDC, 3 package rows20240613_edcd5209-70db-4727-991e-3fdd185d9211.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Testone CIKTESTOSTERONE CYPIONATE, ALCOHOLAsclemed USA, Inc.edcd5209-70db-4727-991e-3fdd185d92112026-01-11Warnings, Adverse reactionsExact identifier
ndc (package): 76420-650-01
ndc (product): 76420-650
ndc11 (package): 76420065001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSNedcd5209-70db-4727-991e-3fdd185d921111
2047882testosterone cypionate 200 MG in 1 ML InjectionPSNedcd5209-70db-4727-991e-3fdd185d921111
835840testosterone cypionate 200 MG/ML Injectable SolutionPSNedcd5209-70db-4727-991e-3fdd185d921111
20478821 ML testosterone cypionate 200 MG/ML InjectionSCDedcd5209-70db-4727-991e-3fdd185d921111
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDedcd5209-70db-4727-991e-3fdd185d921111
835840testosterone cypionate 200 MG/ML Injectable SolutionSCDedcd5209-70db-4727-991e-3fdd185d921111
797544isopropyl alcohol 70 % Medicated PadSYedcd5209-70db-4727-991e-3fdd185d921111
797544isopropyl alcohol 70 % Topical ClothSYedcd5209-70db-4727-991e-3fdd185d921111
797544isopropyl alcohol 70 % Topical SwabSYedcd5209-70db-4727-991e-3fdd185d921111
2047882testosterone cypionate 200 MG per 1 ML InjectionSYedcd5209-70db-4727-991e-3fdd185d921111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-650-01764200650011 KIT in 1 CARTON (76420-650-01) * 1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS * 1.4 mL in 1 POUCH1 kit2016-05-230000-00-00NoNoCurrent