Testosterone
- Product NDC
- 0591-2114
- 11-digit product format
- 005912114
- Labeler code
- 0591
- Product ID
- 0591-2114_6fb6ef6d-5ed8-4565-916e-30e7b117d612
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Testosterone
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA205328
- Marketing category
- ANDA
- Marketing start
- 2017-08-18
- 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 table| Ingredient | Strength |
|---|
| TESTOSTERONE | 30 mg/1.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3XMK78S47O |
| Rxcui | 1599949 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-2114-81 | Testosterone | 1 in 1 CARTON | SOLUTION | 1 | | 20 |
| 0591-2114-81 | Testosterone | 90 mL in 1 BOTTLE, WITH APPLICATOR | SOLUTION | 90 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-2114 | TESTOSTERONE SOLUTION [ACTAVIS PHARMA, INC.] | 18 | Current NDC, Legacy NDC, 2 package rows | 20221201_7227ab2f-c8ef-4bab-92ab-3092182abcc9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-2114-81 | 00591211481 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0591-2114-81) / 90 mL in 1 BOTTLE, WITH APPLICATOR | 2017-08-18 | 0000-00-00 | No | No | Current |