AZMIRO
- Product NDC
- 24338-055
- 11-digit product format
- 243380055
- Labeler code
- 24338
- Product ID
- 24338-055_5cf15fb2-1ba1-4295-9ddf-e98434ccd1c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TESTOSTERONE CYPIONATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Azurity Pharmaceuticals, Inc.
- Application
- NDA216318
- Marketing category
- NDA
- Marketing start
- 2024-10-04
- Substance
- TESTOSTERONE CYPIONATE
- Active strength
- 200 mg/mL
- 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
- AZMIRO
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TESTOSTERONE CYPIONATE | 200 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | M0XW1UBI14 |
| Rxcui | 2047882, 2694309, 2694316, 2694320 |
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 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
| ed2e617f-f28a-1df1-f9fc-c79702f31271 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 24338-055-01 | AZMIRO | 1 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 1 | 3 | |
| 24338-055-01 | AZMIRO | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 24338-055-01 | ML - Milliliter | 24338-055 | 6285ea67-03d0-4030-8601-0862d1e6b59b | 1 | 2024-12-10 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2694320 | AZMIRO 200 MG in 1 ML Injection | PSN | 235b5625-570d-3fba-e063-6394a90aa2d1 | 3 |
| 2694316 | AZMIRO 200 MG in 1 ML Prefilled Syringe | PSN | 235b5625-570d-3fba-e063-6394a90aa2d1 | 3 |
| 2047882 | testosterone cypionate 200 MG in 1 ML Injection | PSN | 235b5625-570d-3fba-e063-6394a90aa2d1 | 3 |
| 2694309 | testosterone cypionate 200 MG in 1 ML Prefilled Syringe | PSN | 235b5625-570d-3fba-e063-6394a90aa2d1 | 3 |
| 2694320 | 1 ML testosterone cypionate 200 MG/ML Injection [Azmiro] | SBD | 235b5625-570d-3fba-e063-6394a90aa2d1 | 3 |
| 2694316 | 1 ML testosterone cypionate 200 MG/ML Prefilled Syringe [Azmiro] | SBD | 235b5625-570d-3fba-e063-6394a90aa2d1 | 3 |
| 2047882 | 1 ML testosterone cypionate 200 MG/ML Injection | SCD | 235b5625-570d-3fba-e063-6394a90aa2d1 | 3 |
| 2694309 | 1 ML testosterone cypionate 200 MG/ML Prefilled Syringe | SCD | 235b5625-570d-3fba-e063-6394a90aa2d1 | 3 |
| 2694320 | Azmiro 200 MG per 1 ML Injection | SY | 235b5625-570d-3fba-e063-6394a90aa2d1 | 3 |
| 2694316 | Azmiro 200 MG per 1 ML Prefilled Syringe | SY | 235b5625-570d-3fba-e063-6394a90aa2d1 | 3 |
| 2047882 | testosterone cypionate 200 MG per 1 ML Injection | SY | 235b5625-570d-3fba-e063-6394a90aa2d1 | 3 |
| 2694309 | testosterone cypionate 200 MG per 1 ML Prefilled Syringe | SY | 235b5625-570d-3fba-e063-6394a90aa2d1 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 24338-055-01 | 24338005501 | 1 SYRINGE, GLASS in 1 CARTON (24338-055-01) / 1 mL in 1 SYRINGE, GLASS | 2024-10-04 | No | No | Current |