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United States · US · US:0116-4010_3479947d-22a8-67e8-e063-6294a90ae41c
Amantadine
In shortageOrange BookUNIISPLATC N04BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXttrium Laboratories, Inc
CountryUS (United States)
ATC codeN04BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110116401016473 mL in 1 BOTTLE (0116-4010-16)
- ndc110116401041100 TRAY in 1 CASE (0116-4010-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4010-10)
Annotations
UNII (FDA Substance ID)
M6Q1EO9TD0
AMANTADINE HYDROCHLORIDE
RxCUI 282415
Orange Book
A075060
AA
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": "0116-4010_3479947d-22a8-67e8-e063-6294a90ae41c",
"productndc": "0116-4010",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "075060",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "50MG/5ML",
"product_no": "001",
"approval_date": "Dec 24, 1998"
}
],
"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",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA075060",
"marketing_category": "ANDA",
"nonproprietary_name": "Amantadine",
"start_marketing_date": "20241105",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N04BB01.
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