🇺🇸
United States · US · US:24338-055_5cf15fb2-1ba1-4295-9ddf-e98434ccd1c2
AZMIRO
In shortageOrange BookUNIISPLATC G03BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAzurity Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG03BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1124338055011 SYRINGE, GLASS in 1 CARTON (24338-055-01) / 1 mL in 1 SYRINGE, GLASS
Annotations
UNII (FDA Substance ID)
M0XW1UBI14
TESTOSTERONE CYPIONATE
RxCUI 835827
Orange Book
N216318
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Testosterone Gel; Gel, Metered
Raw payload (JSON)
{
"unii": {
"unii": "M0XW1UBI14",
"rxcui": "835827",
"inchikey": "HPFVBGJFAYZEBE-ZLQWOROUSA-N",
"display_name": "TESTOSTERONE CYPIONATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR",
"spl_meta": {
"235b5625-570d-3fba-e063-6394a90aa2d1": {
"match": "brand_token",
"title": "AZMIRO (TESTOSTERONE CYPIONATE) INJECTION, SOLUTION [AZURITY PHARMACEUTICALS, INC.]",
"spl_version": "3",
"published_date": "2025-07-28"
}
},
"productid": "24338-055_5cf15fb2-1ba1-4295-9ddf-e98434ccd1c2",
"productndc": "24338-055",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "216318",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "200MG/ML (200MG/ML)",
"product_no": "001",
"approval_date": "Jun 2, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TESTOSTERONE CYPIONATE",
"shortage_reason": "Testosterone Gel; Gel, Metered",
"shortage_status": "current",
"proprietary_name": "AZMIRO",
"active_ingred_unit": "mg/mL",
"application_number": "NDA216318",
"marketing_category": "NDA",
"nonproprietary_name": "TESTOSTERONE CYPIONATE",
"start_marketing_date": "20241004",
"active_numerator_strength": "200"
}Related drugs
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- 🇺🇸AndroGelASCEND Therapeutics U.S., LLC
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- CZANDROGELBesins Healthcare S.A., Ixelles
- CZANDROGELBesins Healthcare S.A., Ixelles
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