Testosterone Cypionate
- Product NDC
- 0143-9005
- 11-digit product format
- 001439005
- Labeler code
- 0143
- Product ID
- 0143-9005_9aa4f810-6b6e-4959-bfa3-b15b088ef380
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Testosterone Cypionate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA091244
- Marketing category
- ANDA
- Marketing start
- 2021-11-22
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Testosterone Cypionate
- Listing expiration
- 2027-12-31
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 |
|---|
| 0143-9005-01 | Testosterone Cypionate | 1 in 1 CARTON | INJECTION | 1 | | 3 |
| 0143-9005-01 | Testosterone Cypionate | 10 mL in 1 VIAL | INJECTION | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9005 | TESTOSTERONE CYPIONATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20211123_5ca67491-4b30-4a47-af0a-be250215d1f0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0143-9005-01 | 00143900501 | 1 VIAL in 1 CARTON (0143-9005-01) / 10 mL in 1 VIAL | 1 vial | 2021-11-22 | 0000-00-00 | No | No | Current |