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United States · US · US:10135-693_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
- ndc111013569301100 CAPSULE, GELATIN COATED in 1 BOTTLE (10135-693-01)
- ndc111013569305500 CAPSULE, GELATIN COATED in 1 BOTTLE (10135-693-05)
Annotations
UNII (FDA Substance ID)
M6Q1EO9TD0
AMANTADINE HYDROCHLORIDE
RxCUI 282415
Orange Book
A210129
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": "10135-693_3e752827-026e-d525-e063-6394a90a7e80",
"productndc": "10135-693",
"dosage_form": "CAPSULE, GELATIN COATED",
"orange_book": {
"appl_no": "210129",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Mar 2, 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": "ANDA210129",
"marketing_category": "ANDA",
"nonproprietary_name": "Amantadine Hydrochloride",
"start_marketing_date": "20200301",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N04BB01.
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