Testosterone Cypionate
- Product NDC
- 76420-645
- 11-digit product format
- 764200645
- Labeler code
- 76420
- Product ID
- 76420-645_0aa2a70c-f281-4165-e063-6294a90ace32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Testosterone Cypionate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA040530
- Marketing category
- ANDA
- Marketing start
- 2007-12-21
- 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| Ingredient | Strength |
|---|
| TESTOSTERONE CYPIONATE | 200 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M0XW1UBI14 |
| Rxcui | 835840 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-645-10 | Testosterone Cypionate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
| 76420-645-10 | Testosterone Cypionate | 10 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-645 | TESTOSTERONE CYPIONATE INJECTION, SOLUTION [ASCLEMED USA, INC.] | 1 | Current NDC, 2 package rows | 20231123_54aee197-7c9c-479f-8a4d-a8d4d31f40c1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-645-10 | 76420064510 | 1 VIAL, GLASS in 1 CARTON (76420-645-10) / 10 mL in 1 VIAL, GLASS | 2023-11-20 | No | No | Historical |