TESTOSTERONE
- Product NDC
- 62332-552
- 11-digit product format
- 623320552
- Labeler code
- 62332
- Product ID
- 62332-552_62220e49-3381-41e3-a801-7f9a1e07c3b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TESTOSTERONE
- Dosage form
- GEL
- Route
- TRANSDERMAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA213922
- Marketing category
- ANDA
- Marketing start
- 2021-03-04
- Substance
- TESTOSTERONE
- Active strength
- 16.2 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TESTOSTERONE | 16.2 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3XMK78S47O |
| Rxcui | 1597076 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62332-552-88 | TESTOSTERONE | 1 in 1 CARTON | GEL | 1 | | 8 |
| 62332-552-88 | TESTOSTERONE | 88 g in 1 BOTTLE, PUMP | GEL | 88 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-552 | TESTOSTERONE GEL [ALEMBIC PHARMACEUTICALS INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20231209_21705fce-bc6c-41f6-aa92-fa6fc1c22fb6.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 |
|---|
| 62332-552-88 | 62332055288 | 1 BOTTLE, PUMP in 1 CARTON (62332-552-88) / 88 g in 1 BOTTLE, PUMP | 2021-03-04 | 0000-00-00 | No | No | Current |