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United States · US · US:0002-1243_08af2d71-07e5-474b-98a2-eb5be9bcf894
Mounjaro
Orange BookUNIISPLATC A10BX16
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEli Lilly and Company
CountryUS (United States)
ATC codeA10BX16
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100021243011 VIAL, SINGLE-DOSE in 1 CARTON (0002-1243-01) / .5 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
OYN3CCI6QE
TIRZEPATIDE
RxCUI 2601723
Orange Book
N215866
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "OYN3CCI6QE",
"rxcui": "2601723",
"inchikey": null,
"display_name": "TIRZEPATIDE",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"d2d7da5d-ad07-4228-955f-cf7e355c8cc0": {
"match": "brand_token",
"title": "MOUNJARO (TIRZEPATIDE) INJECTION, SOLUTION MOUNJARO KWIKPEN (TIRZEPATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]",
"spl_version": "38",
"published_date": "2026-05-06"
}
},
"productid": "0002-1243_08af2d71-07e5-474b-98a2-eb5be9bcf894",
"productndc": "0002-1243",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "215866",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2.5MG/0.5ML (2.5MG/0.5ML)",
"product_no": "001",
"approval_date": "May 13, 2022"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "5MG/0.5ML (5MG/0.5ML)",
"product_no": "002",
"approval_date": "May 13, 2022"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "7.5MG/0.5ML (7.5MG/0.5ML)",
"product_no": "003",
"approval_date": "May 13, 2022"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG/0.5ML (10MG/0.5ML)",
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},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "12.5MG/0.5ML (12.5MG/0.5ML)",
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},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "15MG/0.5ML (15MG/0.5ML)",
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},
{
"rs": true,
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},
{
"rs": true,
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},
{
"rs": true,
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},
{
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},
{
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"product_no": "011",
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},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "15MG/0.5ML (15MG/0.5ML)",
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},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG/2.4ML (4.17MG/ML)",
"product_no": "013",
"approval_date": "Jan 7, 2026"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "20MG/2.4ML (8.33MG/ML)",
"product_no": "014",
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},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "30MG/2.4ML (12.5MG/ML)",
"product_no": "015",
"approval_date": "Jan 7, 2026"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "40MG/2.4ML (16.7MG/ML)",
"product_no": "016",
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},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "50MG/2.4ML (20.8MG/ML)",
"product_no": "017",
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},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "60MG/2.4ML (25MG/ML)",
"product_no": "018",
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},
{
"rs": true,
"rld": true,
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"strength": "10MG/2.4ML (4.17MG/ML)",
"product_no": "019",
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},
{
"rs": true,
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"product_no": "020",
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},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "30MG/2.4ML (12.5MG/ML)",
"product_no": "021",
"approval_date": "Jan 20, 2026"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "40MG/2.4ML (16.7MG/ML)",
"product_no": "022",
"approval_date": "Jan 20, 2026"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "50MG/2.4ML (20.8MG/ML)",
"product_no": "023",
"approval_date": "Jan 20, 2026"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "60MG/2.4ML (25MG/ML)",
"product_no": "024",
"approval_date": "Jan 20, 2026"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIRZEPATIDE",
"proprietary_name": "Mounjaro",
"active_ingred_unit": "mg/.5mL",
"application_number": "NDA215866",
"marketing_category": "NDA",
"nonproprietary_name": "tirzepatide",
"start_marketing_date": "20230728",
"active_numerator_strength": "5"
}Related drugs
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