🇺🇸
United States · US · US:61037-484_38fc829b-496d-024d-e063-6294a90a11b5
AMANTADINE HYDROCHLORIDE
In shortageOrange BookUNIISPLATC N04BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBAJAJ MEDICAL, LLC
CountryUS (United States)
ATC codeN04BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116103748403473 mL in 1 BOTTLE (61037-484-03)
Annotations
UNII (FDA Substance ID)
M6Q1EO9TD0
AMANTADINE HYDROCHLORIDE
RxCUI 282415
Orange Book
A075819
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": "61037-484_38fc829b-496d-024d-e063-6294a90a11b5",
"productndc": "61037-484",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "075819",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "50MG/5ML",
"product_no": "001",
"approval_date": "Sep 11, 2002"
}
],
"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": "ANDA075819",
"marketing_category": "ANDA",
"nonproprietary_name": "AMANTADINE HYDROCHLORIDE",
"start_marketing_date": "20250731",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N04BB01.
- NOAmantadin aliudAliud Pharma
- 🇺🇸amantadineAlembic Pharmaceuticals Inc.
- 🇺🇸amantadineAlembic Pharmaceuticals Limited
- 🇺🇸AmantadineNCS HealthCare of KY, LLC dba Vangard Labs
- 🇺🇸AmantadineAlembic Pharmaceuticals Limited
- 🇺🇸AmantadineXttrium Laboratories, Inc
- 🇺🇸AmantadineAlembic Pharmaceuticals Inc.
- 🇺🇸AmantadineAmerican Health Packaging
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.