🇺🇸
United States · US · US:10135-692_3e752827-026e-d525-e063-6394a90a7e80
Amantadine Hydrochloride
In shortageOrange BookUNIISPLATC N04BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMarlex Pharmaceuticals Inc
CountryUS (United States)
ATC codeN04BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc111013569201100 TABLET in 1 BOTTLE (10135-692-01)
- ndc111013569205500 TABLET in 1 BOTTLE (10135-692-05)
Annotations
UNII (FDA Substance ID)
M6Q1EO9TD0
AMANTADINE HYDROCHLORIDE
RxCUI 282415
Orange Book
A210215
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": "10135-692_3e752827-026e-d525-e063-6394a90a7e80",
"productndc": "10135-692",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "210215",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Mar 10, 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 Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210215",
"marketing_category": "ANDA",
"nonproprietary_name": "Amantadine Hydrochloride",
"start_marketing_date": "20200301",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N04BB01.
- NOAmantadin aliudAliud Pharma
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- 🇺🇸amantadineAlembic Pharmaceuticals Limited
- 🇺🇸AmantadineNCS HealthCare of KY, LLC dba Vangard Labs
- 🇺🇸AmantadineAlembic Pharmaceuticals Limited
- 🇺🇸AmantadineXttrium Laboratories, Inc
- 🇺🇸AmantadineAlembic Pharmaceuticals Inc.
- 🇺🇸AmantadineAmerican Health Packaging
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