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United States · US · US:49502-378_97c0bb6f-0f8d-414d-88eb-a1590aeaeb9c
ERMEZA
In shortageOrange BookUNIISPLATC H03AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeH03AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1149502378151 BOTTLE, GLASS in 1 CARTON (49502-378-15) / 150 mL in 1 BOTTLE, GLASS
- ndc1149502378751 BOTTLE, GLASS in 1 CARTON (49502-378-75) / 75 mL in 1 BOTTLE, GLASS
Annotations
UNII (FDA Substance ID)
9J765S329G
LEVOTHYROXINE SODIUM
RxCUI 40144
Orange Book
N215809
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Levothyroxine Sodium Tablet
Raw payload (JSON)
{
"unii": {
"unii": "9J765S329G",
"rxcui": "40144",
"inchikey": "JMHCCAYJTTWMCX-QWPJCUCISA-M",
"display_name": "LEVOTHYROXINE SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"8ceeadb4-18be-46c7-9204-68b4edfbb96b": {
"match": "brand_token",
"title": "ERMEZA (LEVOTHYROXINE SODIUM) SOLUTION [VIATRIS SPECIALTY LLC]",
"spl_version": "6",
"published_date": "2025-11-18"
}
},
"productid": "49502-378_97c0bb6f-0f8d-414d-88eb-a1590aeaeb9c",
"productndc": "49502-378",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "215809",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "150MCG/5ML",
"product_no": "001",
"approval_date": "Apr 29, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVOTHYROXINE SODIUM",
"shortage_reason": "Levothyroxine Sodium Tablet",
"shortage_status": "current",
"proprietary_name": "ERMEZA",
"active_ingred_unit": "ug/mL",
"application_number": "NDA215809",
"marketing_category": "NDA",
"nonproprietary_name": "levothyroxine sodium",
"start_marketing_date": "20221214",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code H03AA01.
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