🇺🇸
United States · US · US:39328-530_f923b293-f2ac-4116-a122-9524fe748aca
Amantadine Hydrochloride
In shortageOrange BookUNIISPLATC N04BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPatrin Pharma, Inc.
CountryUS (United States)
ATC codeN04BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc113932853016473 mL in 1 BOTTLE, PLASTIC (39328-530-16)
- ndc11393285309910 TRAY in 1 CASE (39328-530-99) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (39328-530-10)
Annotations
UNII (FDA Substance ID)
M6Q1EO9TD0
AMANTADINE HYDROCHLORIDE
RxCUI 282415
Orange Book
A214178
AA
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": "39328-530_f923b293-f2ac-4116-a122-9524fe748aca",
"productndc": "39328-530",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "214178",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "50MG/5ML",
"product_no": "001",
"approval_date": "Aug 20, 2021"
}
],
"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/5mL",
"application_number": "ANDA214178",
"marketing_category": "ANDA",
"nonproprietary_name": "amantadine hydrochloride",
"start_marketing_date": "20230811",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N04BB01.
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- 🇺🇸AmantadineAlembic Pharmaceuticals Limited
- 🇺🇸AmantadineXttrium Laboratories, Inc
- 🇺🇸AmantadineAlembic Pharmaceuticals Inc.
- 🇺🇸AmantadineAmerican Health Packaging
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