🇺🇸
United States · US · US:42667-5511_3ab4a3a7-6d2d-ac70-e063-6394a90afb84
Natesto
In shortageOrange BookUNIISPLATC G03BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAcerus Pharmaceuticals Corporation
CountryUS (United States)
ATC codeG03BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1142667551111 APPLICATOR in 1 BOX (42667-5511-1) / 11 g in 1 APPLICATOR
Annotations
UNII (FDA Substance ID)
3XMK78S47O
TESTOSTERONE
RxCUI 10379
Orange Book
N205488
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Testosterone Gel; Gel, Metered
Raw payload (JSON)
{
"unii": {
"unii": "3XMK78S47O",
"rxcui": "10379",
"inchikey": "MUMGGOZAMZWBJJ-DYKIIFRCSA-N",
"display_name": "TESTOSTERONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "NASAL",
"spl_meta": {
"dea6bed1-eaca-11e3-ac10-0800200c9a66": {
"match": "brand_token",
"title": "NATESTO NASAL GEL (TESTOSTERONE) GEL, METERED [ACERUS PHARMACEUTICALS CORPORATION]",
"spl_version": "18",
"published_date": "2025-07-28"
}
},
"productid": "42667-5511_3ab4a3a7-6d2d-ac70-e063-6394a90afb84",
"productndc": "42667-5511",
"dosage_form": "GEL, METERED",
"orange_book": {
"appl_no": "205488",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "5.5MG/0.122GM ACTUATION",
"product_no": "001",
"approval_date": "May 28, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": "CIII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TESTOSTERONE",
"shortage_reason": "Testosterone Gel; Gel, Metered",
"shortage_status": "current",
"proprietary_name": "Natesto",
"active_ingred_unit": "mg/.122g",
"application_number": "NDA205488",
"marketing_category": "NDA",
"nonproprietary_name": "testosterone",
"start_marketing_date": "20200508",
"active_numerator_strength": "5.5"
}Related drugs
Other records sharing ATC code G03BA03.
- GBAndroderm 5mg/24hours transdermal patchesImported (United States)
- GBAndrofeme 1% creamImported (Australia)
- 🇺🇸AndroGelASCEND Therapeutics U.S., LLC
- 🇺🇸AndroGelASCEND Therapeutics U.S., LLC
- 🇺🇸AndroGelASCEND Therapeutics U.S., LLC
- 🇺🇸AndroGelASCEND Therapeutics U.S., LLC
- CZANDROGELBesins Healthcare S.A., Ixelles
- CZANDROGELBesins Healthcare S.A., Ixelles
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