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United States · US · US:71858-0110_4e04737b-8d88-7c75-e063-6394a90a34c0
Tirosint
In shortageOrange BookUNIISPLATC H03AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIBSA Pharma Inc.
CountryUS (United States)
ATC codeH03AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1171858011026 POUCH in 1 CARTON (71858-0110-2) / 5 AMPULE in 1 POUCH (71858-0110-4) / 1 mL in 1 AMPULE (71858-0110-6)
- ndc1171858011056 POUCH in 1 CARTON (71858-0110-5) / 5 AMPULE in 1 POUCH (71858-0110-4) / 1 mL in 1 AMPULE (71858-0110-6)
Annotations
UNII (FDA Substance ID)
9J765S329G
LEVOTHYROXINE SODIUM
RxCUI 40144
Orange Book
N206977
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": {
"5d378add-f13d-40f2-99dc-0f2340ab44b7": {
"match": "brand_token",
"title": "TIROSINT SOL (LEVOTHYROXINE SODIUM) SOLUTION [IBSA PHARMA INC.]",
"spl_version": "18",
"published_date": "2026-03-30"
}
},
"productid": "71858-0110_4e04737b-8d88-7c75-e063-6394a90a34c0",
"productndc": "71858-0110",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "206977",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "13MCG/ML",
"product_no": "001",
"approval_date": "Dec 15, 2016"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "25MCG/ML",
"product_no": "002",
"approval_date": "Dec 15, 2016"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "50MCG/ML",
"product_no": "003",
"approval_date": "Dec 15, 2016"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "75MCG/ML",
"product_no": "004",
"approval_date": "Dec 15, 2016"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "88MCG/ML",
"product_no": "005",
"approval_date": "Dec 15, 2016"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "100MCG/ML",
"product_no": "006",
"approval_date": "Dec 15, 2016"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "112MCG/ML",
"product_no": "007",
"approval_date": "Dec 15, 2016"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "125MCG/ML",
"product_no": "008",
"approval_date": "Dec 15, 2016"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "137MCG/ML",
"product_no": "009",
"approval_date": "Dec 15, 2016"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "150MCG/ML",
"product_no": "010",
"approval_date": "Dec 15, 2016"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "175MCG/ML",
"product_no": "011",
"approval_date": "Dec 15, 2016"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "200MCG/ML",
"product_no": "012",
"approval_date": "Dec 15, 2016"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "37.5MCG/ML",
"product_no": "013",
"approval_date": "Jan 13, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "44MCG/ML",
"product_no": "014",
"approval_date": "Jan 13, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "62.5MCG/ML",
"product_no": "015",
"approval_date": "Jan 13, 2021"
}
],
"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": "Tirosint",
"active_ingred_unit": "ug/mL",
"application_number": "NDA206977",
"marketing_category": "NDA",
"nonproprietary_name": "Levothyroxine Sodium",
"start_marketing_date": "20190301",
"active_numerator_strength": "25"
}Related drugs
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