testosterone
- Product NDC
- 63629-9310
- 11-digit product format
- 636299310
- Labeler code
- 63629
- Product ID
- 63629-9310_6f355520-8406-4b95-9843-818049cf2948
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- testosterone
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA204255
- Marketing category
- ANDA
- Marketing start
- 2017-06-28
- Substance
- TESTOSTERONE
- Active strength
- 30 mg/1.5mL
- 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 | 30 mg/1.5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 3XMK78S47O |
| Rxcui | 1599949 |
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 |
|---|---|---|---|---|---|---|
| 63629-9310-1 | testosterone | 1 in 1 CARTON | SOLUTION | 1 | 106 | |
| 63629-9310-1 | testosterone | 110 mL in 1 BOTTLE, PUMP | SOLUTION | 110 | 106 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-9310-1 | ML - Milliliter | 63629-9310 | 55376e35-ceab-4706-add0-b39e6ddd78ee | 1 | 2022-08-04 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-9310 | TESTOSTERONE SOLUTION [BRYANT RANCH PREPACK] | 106 | Current NDC, Legacy NDC, 2 package rows | 20240822_d22a072f-529b-4878-90fc-4365d9dc67e6.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1599949 | testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUAT | PSN | d22a072f-529b-4878-90fc-4365d9dc67e6 | 106 |
| 1599949 | 60 ACTUAT testosterone 30 MG/ACTUAT Topical Solution | SCD | d22a072f-529b-4878-90fc-4365d9dc67e6 | 106 |
| 1599949 | 60 ACTUAT testosterone 30 MG/1.5 ML ACTUAT Topical Solution | SY | d22a072f-529b-4878-90fc-4365d9dc67e6 | 106 |
| 1599949 | testosterone (as testosterone propionate) 2 % Topical Solution | SY | d22a072f-529b-4878-90fc-4365d9dc67e6 | 106 |
| 1599949 | testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUAT | SY | d22a072f-529b-4878-90fc-4365d9dc67e6 | 106 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63629-9310-1 | 63629931001 | 1 BOTTLE, PUMP in 1 CARTON (63629-9310-1) / 110 mL in 1 BOTTLE, PUMP | 2022-07-06 | 0000-00-00 | No | No | Current |