Testosterone Gel, 1%
- Product NDC
- 21922-019
- 11-digit product format
- 219220019
- Labeler code
- 21922
- Product ID
- 21922-019_afa51eef-714f-4b19-8c35-debee6cb00c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Testosterone Gel, 1%
- Dosage form
- GEL
- Route
- TRANSDERMAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA212984
- Marketing category
- ANDA
- Marketing start
- 2021-01-10
- 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
- Testosterone Gel, 1%
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TESTOSTERONE | 10 mg/g |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 3XMK78S47O |
| Rxcui | 1596780, 1597123, 1597129 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2db4fc38-a116-b0ab-3dae-57df54e5f212 | Product name | 2 | 20250121 |
| 386d1b2a-e9b7-0c83-111f-2a77b92895b3 | Product name | 5 | 20240422 |
| 7d55b53c-798b-47ae-992b-3921493a8303 | Product name | 1 | 20230322 |
| 8d753fd6-75b2-4f12-bcbf-339392960afa | Product name | 1 | 20230303 |
| 4fbda828-a5be-46fe-83ec-a88da4359919 | Product name | 1 | 20230104 |
| 93cc9bee-8bdc-273d-ec7f-c2c52535317a | Product name | 7 | 20210902 |
| a6389cd1-36d1-4b5c-9934-1139bee93605 | Product name | 5 | 20210601 |
| f4f0889f-ee8b-471f-9a37-02a035280637 | Product name | 1 | 20200122 |
| 09e1afd3-f431-4380-82c5-438884c25615 | Product name | 1 | 20190111 |
| a6389cd1-36d1-4b5c-9934-1139bee93605 | Product name | 3 | 20171212 |
| 502efed8-01a5-ef6a-61c6-fe8302b6e26b | Product name | 2 | 20171113 |
| 8b700cfd-17dd-41a2-90f5-a80ae8a989a2 | Product name | 1 | 20171113 |
| 9ce0e503-4ae7-2c6a-39ae-85285c29db68 | Product name | 2 | 20171113 |
| 96bdf4b3-71cd-433d-9723-89e50f852992 | Product name | 1 | 20150810 |
| ed2e617f-f28a-1df1-f9fc-c79702f31271 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21922-019-02 | Testosterone Gel, 1% | 5 g in 1 PACKET | GEL | 5 | 8 | |
| 21922-019-02 | Testosterone Gel, 1% | 30 in 1 CARTON | GEL | 30 | 8 | |
| 21922-019-47 | Testosterone Gel, 1% | 75 g in 1 CONTAINER | GEL | 75 | 8 | |
| 21922-019-47 | Testosterone Gel, 1% | 2 in 1 CARTON | GEL | 2 | 8 | |
| 21922-019-52 | Testosterone Gel, 1% | 25 g in 1 PACKET | GEL | 25 | 8 | |
| 21922-019-52 | Testosterone Gel, 1% | 30 in 1 CARTON | GEL | 30 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21922-019-02 | GM - Gram | 21922-019 | 7654cb76-0f0f-4d47-9f3c-3cae35e3c393 | 1 | 2022-02-07 |
| 21922-019-47 | GM - Gram | 21922-019 | 3098efbf-aebe-431f-b2e4-0f64664f45bf | 1 | 2024-07-12 |
| 21922-019-52 | GM - Gram | 21922-019 | ea754375-9601-4a9e-9cf7-774c5a394590 | 1 | 2025-02-10 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1597129 | testosterone 1 % (50 MG / 5 GM) Transdermal Gel | PSN | 353de205-d642-4f26-875b-b9ea4707a755 | 101 |
| 1597129 | 5000 MG testosterone 0.01 MG/MG Topical Gel | SCD | 353de205-d642-4f26-875b-b9ea4707a755 | 101 |
| 1597129 | testosterone 50 MG Transdermal Gel, 5 GM | SY | 353de205-d642-4f26-875b-b9ea4707a755 | 101 |
| 1596780 | testosterone 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUAT | PSN | 7d655d6d-01da-488c-bd4e-c7fbe0ace38c | 8 |
| 1597123 | testosterone 1 % (25 MG / 2.5 GM) Transdermal Gel | PSN | 7d655d6d-01da-488c-bd4e-c7fbe0ace38c | 8 |
| 1597129 | testosterone 1 % (50 MG / 5 GM) Transdermal Gel | PSN | 7d655d6d-01da-488c-bd4e-c7fbe0ace38c | 8 |
| 1597123 | 2500 MG testosterone 0.01 MG/MG Topical Gel | SCD | 7d655d6d-01da-488c-bd4e-c7fbe0ace38c | 8 |
| 1597129 | 5000 MG testosterone 0.01 MG/MG Topical Gel | SCD | 7d655d6d-01da-488c-bd4e-c7fbe0ace38c | 8 |
| 1596780 | 60 ACTUAT testosterone 12.5 MG/ACTUAT Topical Gel | SCD | 7d655d6d-01da-488c-bd4e-c7fbe0ace38c | 8 |
| 1597123 | testosterone 1 % Transdermal Gel, 2.5 GM | SY | 7d655d6d-01da-488c-bd4e-c7fbe0ace38c | 8 |
| 1596780 | testosterone 12.5 MG/ACTUAT Transdermal Gel Pump, 60 ACTUAT | SY | 7d655d6d-01da-488c-bd4e-c7fbe0ace38c | 8 |
| 1597129 | testosterone 50 MG Transdermal Gel, 5 GM | SY | 7d655d6d-01da-488c-bd4e-c7fbe0ace38c | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 21922-019-02 | 21922001902 | 30 PACKET in 1 CARTON (21922-019-02) / 5 g in 1 PACKET | 30 packet | 2021-01-10 | 0000-00-00 | No | No | Current |
| 21922-019-47 | 21922001947 | 2 CONTAINER in 1 CARTON (21922-019-47) / 75 g in 1 CONTAINER | 2 container | 2024-02-14 | No | No | Current | |
| 21922-019-52 | 21922001952 | 30 PACKET in 1 CARTON (21922-019-52) / 25 g in 1 PACKET | 30 packet | 2024-08-12 | No | No | Current |