Testosterone
- Product NDC
- 43598-304
- 11-digit product format
- 435980304
- Labeler code
- 43598
- Product ID
- 43598-304_e1612112-46cf-11c4-9e02-9178073b50ab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Testosterone
- Dosage form
- GEL, METERED
- Route
- TRANSDERMAL
- Labeler
- Dr. Reddy's Laboratories, Inc.
- Application
- ANDA208620
- Marketing category
- ANDA
- Marketing start
- 2019-04-12
- Substance
- TESTOSTERONE
- Active strength
- 1.62 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 | 1.62 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3XMK78S47O |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-304-88 | Testosterone | 88 g in 1 BOTTLE, PUMP | GEL, METERED | 88 | | 7 |
| 43598-304-88 | Testosterone | 1 in 1 CARTON | GEL, METERED | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-304 | TESTOSTERONE GEL, METERED [DR. REDDY'S LABORATORIES, INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20190618_ccadef00-3d5f-f926-e0fb-8dabe859f271.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43598-304-88 | 43598030488 | 1 BOTTLE, PUMP in 1 CARTON (43598-304-88) / 88 g in 1 BOTTLE, PUMP | 2019-04-12 | 0000-00-00 | No | No | Current |