FDA.reportPublic FDA data

testosterone cypionate

Product NDC
47781-910
11-digit product format
477810910
Labeler code
47781
Product ID
47781-910_7b64b3e8-2013-fc50-c8db-926c9d1c4220
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone cypionate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Alvogen Inc.
Application
ANDA207742
Marketing category
ANDA
Marketing start
2022-11-02
Substance
TESTOSTERONE CYPIONATE
Active strength
200 mg/mL
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
testosterone cypionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE CYPIONATE200 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM0XW1UBI14
Rxcui835840, 2047882

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47781-910-22testosterone cypionate10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION104
47781-910-91testosterone cypionate10 in 1 CARTONINJECTION, SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-910-22ML - Milliliter47781-9103ffef5b1-6f0a-4908-abfb-7f00c818c47912023-02-06
47781-910-91ML - Milliliter47781-9108a86a484-6276-4f85-a545-69ef2013eed712023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-910TESTOSTERONE CYPIONATE INJECTION, SOLUTION [ALVOGEN INC.]3Current NDC, Legacy NDC, 2 package rows20241012_ed65346b-31bc-f872-516d-78d5ab70229e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047882testosterone cypionate 200 MG in 1 ML InjectionPSNed65346b-31bc-f872-516d-78d5ab70229e4
835840testosterone cypionate 200 MG/ML Injectable SolutionPSNed65346b-31bc-f872-516d-78d5ab70229e4
20478821 ML testosterone cypionate 200 MG/ML InjectionSCDed65346b-31bc-f872-516d-78d5ab70229e4
835840testosterone cypionate 200 MG/ML Injectable SolutionSCDed65346b-31bc-f872-516d-78d5ab70229e4
2047882testosterone cypionate 200 MG per 1 ML InjectionSYed65346b-31bc-f872-516d-78d5ab70229e4
2047882testosterone cypionate 200 MG in 1 ML InjectionPSNffb1ae64-9026-44c9-83a0-32058957ecc91
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN346604c7-22d0-60c5-e063-6394a90abf0b1
835840testosterone cypionate 200 MG/ML Injectable SolutionPSNffb1ae64-9026-44c9-83a0-32058957ecc91
20478821 ML testosterone cypionate 200 MG/ML InjectionSCDffb1ae64-9026-44c9-83a0-32058957ecc91
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD346604c7-22d0-60c5-e063-6394a90abf0b1
835840testosterone cypionate 200 MG/ML Injectable SolutionSCDffb1ae64-9026-44c9-83a0-32058957ecc91
2047882testosterone cypionate 200 MG per 1 ML InjectionSYffb1ae64-9026-44c9-83a0-32058957ecc91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-910-224778109102210 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
47781-910-914778109109110 VIAL, MULTI-DOSE in 1 CARTON (47781-910-91) / 10 mL in 1 VIAL, MULTI-DOSE (47781-910-22) 2022-11-020000-00-00NoNoCurrent