Depo-Testosterone
- Product NDC
- 76420-425
- 11-digit product format
- 764200425
- Labeler code
- 76420
- Product ID
- 76420-425_3d534b61-bcc6-9c44-e063-6294a90a1b6b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- testosterone cypionate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA085635
- Marketing category
- ANDA
- Marketing start
- 1979-07-25
- Substance
- TESTOSTERONE CYPIONATE
- Active strength
- 100 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
- Depo-Testosterone
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TESTOSTERONE CYPIONATE | 100 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | M0XW1UBI14 |
| Rxcui | 835829, 835831 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2db4fc38-a116-b0ab-3dae-57df54e5f212 | Product name | 2 | 20250121 |
| 386d1b2a-e9b7-0c83-111f-2a77b92895b3 | Product name | 5 | 20240422 |
| 7d55b53c-798b-47ae-992b-3921493a8303 | Product name | 1 | 20230322 |
| 8d753fd6-75b2-4f12-bcbf-339392960afa | Product name | 1 | 20230303 |
| 4fbda828-a5be-46fe-83ec-a88da4359919 | Product name | 1 | 20230104 |
| 93cc9bee-8bdc-273d-ec7f-c2c52535317a | Product name | 7 | 20210902 |
| a6389cd1-36d1-4b5c-9934-1139bee93605 | Product name | 5 | 20210601 |
| f4f0889f-ee8b-471f-9a37-02a035280637 | Product name | 1 | 20200122 |
| 09e1afd3-f431-4380-82c5-438884c25615 | Product name | 1 | 20190111 |
| a6389cd1-36d1-4b5c-9934-1139bee93605 | Product name | 3 | 20171212 |
| 502efed8-01a5-ef6a-61c6-fe8302b6e26b | Product name | 2 | 20171113 |
| 8b700cfd-17dd-41a2-90f5-a80ae8a989a2 | Product name | 1 | 20171113 |
| 9ce0e503-4ae7-2c6a-39ae-85285c29db68 | Product name | 2 | 20171113 |
| 96bdf4b3-71cd-433d-9723-89e50f852992 | Product name | 1 | 20150810 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
| ed2e617f-f28a-1df1-f9fc-c79702f31271 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76420-425-10 | Depo-Testosterone | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 2 | |
| 76420-425-10 | Depo-Testosterone | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | 2 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 835831 | Depo-Testosterone 100 MG/ML Injectable Solution | PSN | 2f72be32-ede6-44d9-88a0-0653b53a3e47 | 2 |
| 835829 | testosterone cypionate 100 MG/ML Injectable Solution | PSN | 2f72be32-ede6-44d9-88a0-0653b53a3e47 | 2 |
| 835831 | testosterone cypionate 100 MG/ML Injectable Solution [Depo-testosterone] | SBD | 2f72be32-ede6-44d9-88a0-0653b53a3e47 | 2 |
| 835829 | testosterone cypionate 100 MG/ML Injectable Solution | SCD | 2f72be32-ede6-44d9-88a0-0653b53a3e47 | 2 |
| 835831 | Depo-testosterone 100 MG/ML Injectable Solution | SY | 2f72be32-ede6-44d9-88a0-0653b53a3e47 | 2 |
| 835829 | testosterone cypionate 1000 MG per 10 ML Injectable Solution | SY | 2f72be32-ede6-44d9-88a0-0653b53a3e47 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 76420-425-10 | 76420042510 | 1 VIAL in 1 CARTON (76420-425-10) / 10 mL in 1 VIAL | 1 vial | 2025-08-08 | No | No | Historical |