Testosterone
- Product NDC
- 72603-265
- 11-digit product format
- 726030265
- Labeler code
- 72603
- Product ID
- 72603-265_7a7672b6-e8fa-c352-35d6-6e9392ad5a4c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Testosterone
- Dosage form
- GEL, METERED
- Route
- TRANSDERMAL
- Labeler
- Northstar Rx LLC
- Application
- ANDA210835
- Marketing category
- ANDA
- Marketing start
- 2024-01-24
- Substance
- TESTOSTERONE
- Active strength
- 20.25 mg/1.25g
- 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TESTOSTERONE | 20.25 mg/1.25g |
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 |
|---|
| 72603-265-01 | Testosterone | 88 g in 1 BOTTLE, PUMP | GEL, METERED | 88 | | 5 |
| 72603-265-01 | Testosterone | 1 in 1 CARTON | GEL, METERED | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72603-265 | TESTOSTERONE GEL, METERED [NORTHSTAR RX LLC] | 4 | Current NDC, 2 package rows | 20250523_65981b8a-d5cc-1964-7eac-a07f032c2571.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-265-01 | 72603026501 | 1 BOTTLE, PUMP in 1 CARTON (72603-265-01) / 88 g in 1 BOTTLE, PUMP | 2024-01-24 | No | No | Current |