testosterone
- Product NDC
- 16714-968
- 11-digit product format
- 167140968
- Labeler code
- 16714
- Product ID
- 16714-968_136b02e0-e440-45ea-9b1f-3ad58db0c710
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- testosterone
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Northstar Rx LLC
- Application
- ANDA205781
- Marketing category
- ANDA
- Marketing start
- 2019-11-06
- Substance
- TESTOSTERONE
- Active strength
- 20.25 mg/1.25g
- 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 | 20.25 mg/1.25g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3XMK78S47O |
| Rxcui | 1597120, 1597126 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-968-01 | testosterone | 1.25 g in 1 PACKET | GEL | 1.25 | | 10 |
| 16714-968-02 | testosterone | 30 in 1 CARTON | GEL | 30 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-968 | TESTOSTERONE GEL [NORTHSTAR RX LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240315_2d55b825-8eab-4091-bdf2-9c52d111b8eb.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 |
|---|
| 16714-968-01 | 16714096801 | 1.25 g in 1 PACKET | 1.25 g | | | | | Historical |
| 16714-968-02 | 16714096802 | 30 PACKET in 1 CARTON (16714-968-02) / 1.25 g in 1 PACKET (16714-968-01) | 30 packet | 2019-11-06 | 0000-00-00 | No | No | Current |