Testosterone
- Product NDC
- 24979-078
- 11-digit product format
- 249790078
- Labeler code
- 24979
- Product ID
- 24979-078_183542a9-eb31-4328-9c28-17264a898d03
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Testosterone
- Dosage form
- GEL
- Route
- TRANSDERMAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- ANDA209390
- Marketing category
- ANDA
- Marketing start
- 2019-12-31
- Substance
- TESTOSTERONE
- Active strength
- 16.2 mg/g
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TESTOSTERONE | 16.2 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3XMK78S47O |
| Rxcui | 1597076 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 24979-078-15 | Testosterone | 88 g in 1 BOTTLE, PUMP | GEL | 88 | | 5 |
| 24979-078-15 | Testosterone | 1 in 1 CARTON | GEL | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 24979-078 | TESTOSTERONE GEL [UPSHER-SMITH LABORATORIES, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250110_10dab294-6a43-4bb3-9d91-2d200c624ffb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 24979-078-15 | 24979007815 | 1 BOTTLE, PUMP in 1 CARTON (24979-078-15) > 88 g in 1 BOTTLE, PUMP | 2019-12-31 | 0000-00-00 | No | No | Current |