Testosterone
- Product NDC
- 66993-954
- 11-digit product format
- 669930954
- Labeler code
- 66993
- Product ID
- 66993-954_c9fee58e-0843-4cf3-8d60-c578dc9a288f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- testosterone
- Dosage form
- GEL
- Route
- TRANSDERMAL
- Labeler
- Prasco Laboratories
- Application
- NDA021015
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2025-05-19
- Substance
- TESTOSTERONE
- Active strength
- 25 mg/2.5g
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TESTOSTERONE | 25 mg/2.5g |
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 |
|---|---|---|---|---|---|---|
| 66993-954-30 | Testosterone | 30 in 1 CARTON | GEL | 30 | 3 | |
| 66993-954-30 | Testosterone | 2.5 g in 1 PACKET | GEL | 2.5 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66993-954-30 | GM - Gram | 66993-954 | 66f5714c-da1d-43ec-82e0-914e04f824e7 | 1 | 2025-12-16 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1596780 | testosterone 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUAT | PSN | 68b2375d-0365-4797-bc3d-63531c9f42fd | 3 |
| 1597123 | testosterone 1 % (25 MG / 2.5 GM) Transdermal Gel | PSN | 68b2375d-0365-4797-bc3d-63531c9f42fd | 3 |
| 1597129 | testosterone 1 % (50 MG / 5 GM) Transdermal Gel | PSN | 68b2375d-0365-4797-bc3d-63531c9f42fd | 3 |
| 1597123 | 2500 MG testosterone 0.01 MG/MG Topical Gel | SCD | 68b2375d-0365-4797-bc3d-63531c9f42fd | 3 |
| 1597129 | 5000 MG testosterone 0.01 MG/MG Topical Gel | SCD | 68b2375d-0365-4797-bc3d-63531c9f42fd | 3 |
| 1596780 | 60 ACTUAT testosterone 12.5 MG/ACTUAT Topical Gel | SCD | 68b2375d-0365-4797-bc3d-63531c9f42fd | 3 |
| 1597123 | testosterone 1 % Transdermal Gel, 2.5 GM | SY | 68b2375d-0365-4797-bc3d-63531c9f42fd | 3 |
| 1596780 | testosterone 12.5 MG/ACTUAT Transdermal Gel Pump, 60 ACTUAT | SY | 68b2375d-0365-4797-bc3d-63531c9f42fd | 3 |
| 1597129 | testosterone 50 MG Transdermal Gel, 5 GM | SY | 68b2375d-0365-4797-bc3d-63531c9f42fd | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 66993-954-30 | 66993095430 | 30 PACKET in 1 CARTON (66993-954-30) / 2.5 g in 1 PACKET | 30 packet | 2025-12-01 | No | No | Current |