🇺🇸
United States · US · US:0121-0646_0d5911e6-e5b6-4013-98ec-773d9ec62dec
AMANTADINE HYDROCHLORIDE
In shortageOrange BookUNIISPLATC N04BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPAI Holdings, LLC dba PAI Pharma
CountryUS (United States)
ATC codeN04BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11012106461010 TRAY in 1 CASE (0121-0646-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE
- ndc110121064616473 mL in 1 BOTTLE (0121-0646-16)
Annotations
UNII (FDA Substance ID)
M6Q1EO9TD0
AMANTADINE HYDROCHLORIDE
RxCUI 282415
Orange Book
A074509
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": "0121-0646_0d5911e6-e5b6-4013-98ec-773d9ec62dec",
"productndc": "0121-0646",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "074509",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "50MG/5ML",
"product_no": "001",
"approval_date": "Jul 17, 1995"
}
],
"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": "ANDA074509",
"marketing_category": "ANDA",
"nonproprietary_name": "AMANTADINE HYDROCHLORIDE",
"start_marketing_date": "19950717",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N04BB01.
Access this data programmatically
Query AMANTADINE HYDROCHLORIDE 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.