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United States · US · US:82347-0010_4dde84bb-3bd3-6722-e063-6394a90a4c09
Levothyroxine Sodium
In shortageOrange BookUNIISPLATC H03AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerYARAL Pharma Inc.
CountryUS (United States)
ATC codeH03AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1182347001043 BLISTER PACK in 1 CARTON (82347-0010-4) / 10 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
9J765S329G
LEVOTHYROXINE SODIUM
RxCUI 40144
Orange Book
N021924
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": {
"5852d874-1ebc-49ff-b6c2-1dd513fca784": {
"match": "brand_token",
"title": "LEVOTHYROXINE SODIUM TABLET [BRYANT RANCH PREPACK]",
"spl_version": "102",
"published_date": "2026-05-28"
}
},
"productid": "82347-0010_4dde84bb-3bd3-6722-e063-6394a90a4c09",
"productndc": "82347-0010",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "021924",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.025MG",
"product_no": "002",
"approval_date": "Oct 13, 2006"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.05MG",
"product_no": "003",
"approval_date": "Oct 13, 2006"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.075MG",
"product_no": "004",
"approval_date": "Oct 13, 2006"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.1MG",
"product_no": "005",
"approval_date": "Oct 13, 2006"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.125MG",
"product_no": "006",
"approval_date": "Oct 13, 2006"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.15MG",
"product_no": "007",
"approval_date": "Oct 13, 2006"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.112MG",
"product_no": "008",
"approval_date": "Oct 2, 2009"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.137MG",
"product_no": "009",
"approval_date": "Oct 2, 2009"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.088MG",
"product_no": "010",
"approval_date": "Oct 2, 2009"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.175MG",
"product_no": "011",
"approval_date": "Apr 25, 2017"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.2MG",
"product_no": "012",
"approval_date": "Apr 25, 2017"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.013MG",
"product_no": "013",
"approval_date": "Aug 1, 2007"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.0375MG",
"product_no": "014",
"approval_date": "Jun 22, 2022"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.044MG",
"product_no": "015",
"approval_date": "Jun 22, 2022"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.0625MG",
"product_no": "016",
"approval_date": "Jun 22, 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": "Levothyroxine Sodium",
"active_ingred_unit": "ug/1",
"application_number": "NDA021924",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "levothyroxine sodium",
"start_marketing_date": "20230301",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code H03AA01.
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