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United States · US · US:67457-153_bd9c578c-322f-41fc-936d-bf9b551a2782
Amiodarone Hydrochloride
Orange BookUNIISPLATC C01BD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeC01BD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11674571530310 VIAL, GLASS in 1 CARTON (67457-153-03) / 3 mL in 1 VIAL, GLASS (67457-153-00)
- ndc11674571530910 VIAL, GLASS in 1 CARTON (67457-153-09) / 9 mL in 1 VIAL, GLASS (67457-153-99)
- ndc1167457153181 VIAL, GLASS in 1 CARTON (67457-153-18) / 18 mL in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
976728SY6Z
AMIODARONE HYDROCHLORIDE
RxCUI 203114
Orange Book
A076217
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "976728SY6Z",
"rxcui": "203114",
"inchikey": "ITPDYQOUSLNIHG-UHFFFAOYSA-N",
"display_name": "AMIODARONE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"f4532f12-3b7a-42ab-9a6c-36fd2a3f192c": {
"match": "brand_token",
"title": "AMIODARONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]",
"spl_version": "103",
"published_date": "2026-05-25"
}
},
"productid": "67457-153_bd9c578c-322f-41fc-936d-bf9b551a2782",
"productndc": "67457-153",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "076217",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "50MG/ML",
"product_no": "001",
"approval_date": "Oct 15, 2002"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMIODARONE HYDROCHLORIDE",
"proprietary_name": "Amiodarone Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA076217",
"marketing_category": "ANDA",
"nonproprietary_name": "amiodarone hydrochloride",
"start_marketing_date": "20021014",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code C01BD01.
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