🇺🇸
United States · US · US:69452-142_372af940-7fe9-4525-e063-6294a90ab417
Amantadine HCl
In shortageOrange BookUNIISPLATC N04BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBionpharma Inc.
CountryUS (United States)
ATC codeN04BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116945214220100 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-142-20)
- ndc116945214230500 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-142-30)
Annotations
UNII (FDA Substance ID)
M6Q1EO9TD0
AMANTADINE HYDROCHLORIDE
RxCUI 282415
Orange Book
A078720
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": "69452-142_372af940-7fe9-4525-e063-6294a90ab417",
"productndc": "69452-142",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "078720",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "May 29, 2008"
}
],
"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 HCl",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078720",
"marketing_category": "ANDA",
"nonproprietary_name": "AMANTADINE HYDROCHLORIDE",
"start_marketing_date": "20160815",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N04BB01.
Access this data programmatically
Query Amantadine HCl and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.