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United States · US · US:82804-196_a3810649-1301-4332-85df-722b36867b1b
Amantadine Hydrochloride
In shortageOrange BookUNIISPLATC N04BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN04BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11828041962020 CAPSULE in 1 BOTTLE (82804-196-20)
Annotations
UNII (FDA Substance ID)
M6Q1EO9TD0
AMANTADINE HYDROCHLORIDE
RxCUI 282415
Orange Book
A212044
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Amantadine Hydrochloride Tablet
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": "82804-196_a3810649-1301-4332-85df-722b36867b1b",
"productndc": "82804-196",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "212044",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "May 21, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMANTADINE HYDROCHLORIDE",
"shortage_reason": "Amantadine Hydrochloride Tablet",
"shortage_status": "current",
"proprietary_name": "Amantadine Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212044",
"marketing_category": "ANDA",
"nonproprietary_name": "Amantadine Hydrochloride",
"start_marketing_date": "20200521",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N04BB01.
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