TESTOSTERONE
- Product NDC
- 21922-030
- 11-digit product format
- 219220030
- Labeler code
- 21922
- Product ID
- 21922-030_b2899b9f-2d03-4492-bf7f-261de187d623
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- testosterone
- Dosage form
- GEL
- Route
- TRANSDERMAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA208620
- Marketing category
- ANDA
- Marketing start
- 2024-06-05
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TESTOSTERONE
- Listing expiration
- 2027-12-31
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 |
|---|
| 21922-030-20 | TESTOSTERONE | 1 in 1 CARTON | GEL | 1 | | 4 |
| 21922-030-20 | TESTOSTERONE | 88 g in 1 BOTTLE, PUMP | GEL | 88 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21922-030 | TESTOSTERONE GEL [ENCUBE ETHICALS PRIVATE LIMITED] | 1 | Current NDC, 2 package rows | 20240608_44a04f66-fd2a-45c7-934e-8f14c023ce14.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 21922-030-20 | 21922003020 | 1 BOTTLE, PUMP in 1 CARTON (21922-030-20) / 88 g in 1 BOTTLE, PUMP | 2024-06-05 | No | No | Historical |