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United States · US · US:46708-586_1ca812f6-6983-4d9a-b08e-a8f7e50054b8
Amantadine
In shortageOrange BookUNIISPLATC N04BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeN04BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc114670858631100 TABLET in 1 BOTTLE (46708-586-31)
- ndc114670858671500 TABLET in 1 BOTTLE (46708-586-71)
Annotations
UNII (FDA Substance ID)
M6Q1EO9TD0
AMANTADINE HYDROCHLORIDE
RxCUI 282415
Orange Book
A214284
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Amantadine Hydrochloride Capsule
Raw payload (JSON)
{
"unii": {
"unii": "M6Q1EO9TD0",
"rxcui": "282415",
"inchikey": "WOLHOYHSEKDWQH-UHFFFAOYSA-N",
"display_name": "AMANTADINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"da693bb0-0cc8-485d-89a7-c8cf28d440f3": {
"match": "brand_token",
"title": "AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]",
"spl_version": "8",
"published_date": "2026-05-20"
}
},
"productid": "46708-586_1ca812f6-6983-4d9a-b08e-a8f7e50054b8",
"productndc": "46708-586",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214284",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Oct 15, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMANTADINE HYDROCHLORIDE",
"shortage_reason": "Amantadine Hydrochloride Capsule",
"shortage_status": "current",
"proprietary_name": "Amantadine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA214284",
"marketing_category": "ANDA",
"nonproprietary_name": "Amantadine",
"start_marketing_date": "20201020",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N04BB01.
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