Testosterone
- Product NDC
- 63629-2352
- 11-digit product format
- 636292352
- Labeler code
- 63629
- Product ID
- 63629-2352_8aba711a-e2ff-4b26-adf8-bf7336585de1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Testosterone
- Dosage form
- GEL, METERED
- Route
- TRANSDERMAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA210835
- Marketing category
- ANDA
- Marketing start
- 2020-05-08
- 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
- 2026-12-31
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 |
|---|
| 63629-2352-1 | Testosterone | 1 in 1 CARTON | GEL, METERED | 1 | | 104 |
| 63629-2352-1 | Testosterone | 88 g in 1 BOTTLE, PUMP | GEL, METERED | 88 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-2352 | TESTOSTERONE GEL, METERED [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 2 package rows | 20240112_6c7d2dec-6492-4d53-b110-61ffeae9ee61.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 |
|---|
| 63629-2352-1 | 63629235201 | 1 BOTTLE, PUMP in 1 CARTON (63629-2352-1) / 88 g in 1 BOTTLE, PUMP | 2020-05-08 | 0000-00-00 | No | No | Current |