AndroGel
- Product NDC
- 17139-501
- 11-digit product format
- 171390501
- Labeler code
- 17139
- Product ID
- 17139-501_14a12387-5802-4ec9-8a75-85faebddd18c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Testosterone
- Dosage form
- GEL
- Route
- TRANSDERMAL
- Labeler
- ASCEND Therapeutics U.S., LLC
- Application
- NDA021015
- Marketing category
- NDA
- Marketing start
- 2023-02-17
- Substance
- TESTOSTERONE
- Active strength
- 10 mg/g
- 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
- AndroGel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TESTOSTERONE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3XMK78S47O |
| Rxcui | 1596780, 1597074, 1597123, 1597124, 1597129, 1597130 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 17139-501-02 | AndroGel | 2 in 1 CARTON | GEL | 2 | | 140 |
| 17139-501-02 | AndroGel | 75 g in 1 BOTTLE, PUMP | GEL | 75 | | 140 |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1597074 | AndroGel 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUAT | PSN | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1597124 | AndroGel 1 % (25MG / 2.5GM) Transdermal Gel | PSN | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1597130 | AndroGel 1 % (50MG / 5GM) Transdermal Gel | PSN | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1596780 | testosterone 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUAT | PSN | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1597123 | testosterone 1 % (25 MG / 2.5 GM) Transdermal Gel | PSN | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1597129 | testosterone 1 % (50 MG / 5 GM) Transdermal Gel | PSN | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1597124 | 2500 MG testosterone 0.01 MG/MG Topical Gel [Androgel] | SBD | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1597130 | 5000 MG testosterone 0.01 MG/MG Topical Gel [Androgel] | SBD | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1597074 | 60 ACTUAT testosterone 12.5 MG/ACTUAT Topical Gel [Androgel] | SBD | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1597123 | 2500 MG testosterone 0.01 MG/MG Topical Gel | SCD | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1597129 | 5000 MG testosterone 0.01 MG/MG Topical Gel | SCD | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1596780 | 60 ACTUAT testosterone 12.5 MG/ACTUAT Topical Gel | SCD | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1597124 | 2500 MG Androgel 0.01 MG/MG Topical Gel | SY | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1597130 | 5000 MG Androgel 0.01 MG/MG Topical Gel | SY | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1597074 | AndroGel 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUAT | SY | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1597124 | Androgel 1 % Transdermal Gel, 2.5 GM | SY | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1597130 | Androgel 1 % Transdermal Gel, 5 GM | SY | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1597123 | testosterone 1 % Transdermal Gel, 2.5 GM | SY | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1596780 | testosterone 12.5 MG/ACTUAT Transdermal Gel Pump, 60 ACTUAT | SY | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
| 1597129 | testosterone 50 MG Transdermal Gel, 5 GM | SY | f4e8fc4e-d6ba-2783-e053-2a95a90a7ae7 | 140 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 17139-501-02 | 17139050102 | 2 BOTTLE, PUMP in 1 CARTON (17139-501-02) / 75 g in 1 BOTTLE, PUMP | 2023-02-17 | No | No | Historical |