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United States · US · US:68083-112_2c1bc6a8-20ff-483a-ae28-fb31fa5f684a
Amiodarone hydrochloride
Orange BookUNIISPLATC C01BD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeC01BD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680831120110 SYRINGE in 1 CARTON (68083-112-01) / 3 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
976728SY6Z
AMIODARONE HYDROCHLORIDE
RxCUI 203114
Orange Book
A077161
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": "68083-112_2c1bc6a8-20ff-483a-ae28-fb31fa5f684a",
"productndc": "68083-112",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "077161",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "50MG/ML",
"product_no": "001",
"approval_date": "Apr 20, 2005"
}
],
"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": "ANDA077161",
"marketing_category": "ANDA",
"nonproprietary_name": "Amiodarone hydrochloride",
"start_marketing_date": "20130715",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code C01BD01.
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