testosterone
- Product NDC
- 63629-8455
- 11-digit product format
- 636298455
- Labeler code
- 63629
- Product ID
- 63629-8455_7829d759-de46-4f02-b3d5-13ca4b4c86e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- testosterone
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA204268
- Marketing category
- ANDA
- Marketing start
- 2018-10-12
- 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 |
|---|
| 63629-8455-1 | testosterone | 88 g in 1 BOTTLE, PUMP | GEL | 88 | | 107 |
| 63629-8455-1 | testosterone | 1 in 1 CARTON | GEL | 1 | | 107 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8455 | TESTOSTERONE GEL [BRYANT RANCH PREPACK] | 106 | Current NDC, Legacy NDC, 2 package rows | 20240808_78384754-5883-46b1-84e7-c063b4b4be82.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 |
|---|
| 63629-8455-1 | 63629845501 | 1 BOTTLE, PUMP in 1 CARTON (63629-8455-1) / 88 g in 1 BOTTLE, PUMP | 2018-10-12 | 0000-00-00 | No | No | Current |