FDA.reportPublic FDA data

Testosterone Cypionate

Product NDC
76420-065
Requested package NDC
76420-065-10
11-digit product format
764200065
Labeler code
76420
Product ID
76420-065_ead2c72c-bd9f-2f0c-e053-2995a90af3cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone cypionate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Asclemed USA, Inc.
Application
ANDA206368
Marketing category
ANDA
Marketing start
2019-05-31
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206368-001TESTOSTERONE CYPIONATETESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2019-04-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A206368-001AO

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A206368-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2019-04-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206368-001AO1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Testosterone CypionateTESTOSTERONE CYPIONATEA-S Medication Solutions5fb0c403-3065-498e-b910-c5988269301a2026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206368
application number: ANDA206368
Testosterone CypionateTESTOSTERONE CYPIONATEWilshire Pharmaceuticals58ff6e0d-cc0a-4455-8254-d883d26a3b6d2025-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206368
application number: ANDA206368
Testosterone CypionateTESTOSTERONE CYPIONATENuCare pgarmaceuticals,Inc.30b453b9-25ef-8262-e063-6394a90a24c22025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206368
application number: ANDA206368
Testosterone CypionateTESTOSTERONE CYPIONATEBryant Ranch Prepack5a0bba6a-e8da-4b12-af63-eb27b1cca9e62025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206368
application number: ANDA206368
Testosterone CypionateTESTOSTERONE CYPIONATEAsclemed USA, Inc.66d4ae28-97c2-42cc-ab5a-a765a623c9442022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206368
application number: ANDA206368
ndc (package): 76420-065-10
ndc (product): 76420-065
ndc11 (package): 76420006510

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M0XW1UBI14Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
66d4ae28-97c2-42cc-ab5a-a765a623c944Available 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
76420-065-10Testosterone Cypionate10 mL in 1 VIAL, MULTI-DOSEINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-065-10ML - Milliliter76420-065aa4a5511-05ba-4dfe-8aa5-d43429dd25eb12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-065TESTOSTERONE CYPIONATE INJECTION [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 1 package rows20221013_66d4ae28-97c2-42cc-ab5a-a765a623c944.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN66d4ae28-97c2-42cc-ab5a-a765a623c9442
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD66d4ae28-97c2-42cc-ab5a-a765a623c9442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-065-107642000651010 mL in 1 VIAL, MULTI-DOSE (76420-065-10) 10 ml2019-12-040000-00-00NoNoCurrent