Natesto
- Product NDC
- 42667-5511
- 11-digit product format
- 426675511
- Labeler code
- 42667
- Product ID
- 42667-5511_3ab4a3a7-6d2d-ac70-e063-6394a90afb84
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- testosterone
- Dosage form
- GEL, METERED
- Route
- NASAL
- Labeler
- Acerus Pharmaceuticals Corporation
- Application
- NDA205488
- Marketing category
- NDA
- Marketing start
- 2020-05-08
- Substance
- TESTOSTERONE
- Active strength
- 5.5 mg/.122g
- 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
- Natesto
- Brand name suffix
- nasal gel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TESTOSTERONE | 5.5 mg/.122g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3XMK78S47O |
| Rxcui | 1596782, 1596784 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42667-5511-1 | Natestonasal gel | 1 in 1 BOX | GEL, METERED | 1 | | 18 |
| 42667-5511-1 | Natestonasal gel | 11 g in 1 APPLICATOR | GEL, METERED | 11 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42667-5511 | NATESTO NASAL GEL (TESTOSTERONE) GEL, METERED [ACERUS PHARMACEUTICALS CORPORATION] | 17 | Current NDC, Legacy NDC, 2 package rows | 20250403_dea6bed1-eaca-11e3-ac10-0800200c9a66.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42667-5511-1 | 42667551101 | 1 APPLICATOR in 1 BOX (42667-5511-1) / 11 g in 1 APPLICATOR | 1 applicator | 2020-05-08 | 0000-00-00 | No | No | Current |