TESTOSTERONE
- Product NDC
- 62332-488
- 11-digit product format
- 623320488
- Labeler code
- 62332
- Product ID
- 62332-488_5ce13b01-78d1-49fa-80c9-6e54d0774e14
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TESTOSTERONE
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA212882
- Marketing category
- ANDA
- Marketing start
- 2021-12-08
- 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 |
|---|
| 62332-488-11 | TESTOSTERONE | 110 mL in 1 BOTTLE, WITH APPLICATOR | SOLUTION | 110 | | 9 |
| 62332-488-11 | TESTOSTERONE | 1 in 1 CARTON | SOLUTION | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-488 | TESTOSTERONE SOLUTION [ALEMBIC PHARMACEUTICALS INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20231209_e39289aa-681c-47ec-9461-52e7f17e5d71.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 |
|---|
| 62332-488-11 | 62332048811 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (62332-488-11) / 110 mL in 1 BOTTLE, WITH APPLICATOR | 2021-12-08 | 0000-00-00 | No | No | Current |