Natesto
- Product NDC
- 69654-239
- 11-digit product format
- 696540239
- Labeler code
- 69654
- Product ID
- 69654-239_ef5a567e-c70f-4cb0-81f9-f053ebf1b26e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- testosterone
- Dosage form
- GEL
- Route
- NASAL
- Labeler
- Aytu BioScience, Inc.
- Application
- NDA205488
- Marketing category
- NDA
- Marketing start
- 2017-09-01
- Marketing end
- 0000-00-00
- Substance
- TESTOSTERONE
- Active strength
- 6 mg/1
- Pharmacologic classes
- Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2db4fc38-a116-b0ab-3dae-57df54e5f212 | Product name | 2 | 20250121 |
| 386d1b2a-e9b7-0c83-111f-2a77b92895b3 | Product name | 5 | 20240422 |
| 7d55b53c-798b-47ae-992b-3921493a8303 | Product name | 1 | 20230322 |
| 8d753fd6-75b2-4f12-bcbf-339392960afa | Product name | 1 | 20230303 |
| 4fbda828-a5be-46fe-83ec-a88da4359919 | Product name | 1 | 20230104 |
| 93cc9bee-8bdc-273d-ec7f-c2c52535317a | Product name | 7 | 20210902 |
| a6389cd1-36d1-4b5c-9934-1139bee93605 | Product name | 5 | 20210601 |
| f4f0889f-ee8b-471f-9a37-02a035280637 | Product name | 1 | 20200122 |
| 09e1afd3-f431-4380-82c5-438884c25615 | Product name | 1 | 20190111 |
| a6389cd1-36d1-4b5c-9934-1139bee93605 | Product name | 3 | 20171212 |
| 502efed8-01a5-ef6a-61c6-fe8302b6e26b | Product name | 2 | 20171113 |
| 8b700cfd-17dd-41a2-90f5-a80ae8a989a2 | Product name | 1 | 20171113 |
| 9ce0e503-4ae7-2c6a-39ae-85285c29db68 | Product name | 2 | 20171113 |
| 96bdf4b3-71cd-433d-9723-89e50f852992 | Product name | 1 | 20150810 |
| ed2e617f-f28a-1df1-f9fc-c79702f31271 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69654-239-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5438-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use NATESTO safely and effectively. See full prescribing information for NATESTO. Natesto (testosterone) nasal gel CIII Initial U.S. Approval: 1953 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69654-239-01 | Natesto | 1 in 1 CARTON | GEL | 1 | 2 | |
| 69654-239-01 | Natesto | 60 in 1 BOTTLE, PUMP | GEL | 60 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69654-239-01 | GM - Gram | 69654-239 | 19a5fa43-fac8-4e1f-9a6f-f5e726c6adba | 1 | 2018-01-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1596782 | Natesto 5.5 MG/ACTUAT Nasal Gel, 60 ACTUAT | PSN | 68d0447b-f75a-4fb2-96ba-de822b74aebb | 2 |
| 1596784 | testosterone 5.5 MG/ACTUAT Nasal Gel, 60 ACTUAT | PSN | 68d0447b-f75a-4fb2-96ba-de822b74aebb | 2 |
| 1596782 | 60 ACTUAT testosterone 5.5 MG/ACTUAT Nasal Gel [Natesto] | SBD | 68d0447b-f75a-4fb2-96ba-de822b74aebb | 2 |
| 1596784 | 60 ACTUAT testosterone 5.5 MG/ACTUAT Nasal Gel | SCD | 68d0447b-f75a-4fb2-96ba-de822b74aebb | 2 |
| 1596782 | Natesto 5.5 MG/ACTUAT Nasal Gel, 60 ACTUAT | SY | 68d0447b-f75a-4fb2-96ba-de822b74aebb | 2 |
| 1596784 | testosterone 5.5 MG/ACTUAT Nasal Gel, 60 ACTUAT | SY | 68d0447b-f75a-4fb2-96ba-de822b74aebb | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 69654-239-01 | 69654023901 | 1 in 1 CARTON | Historical |