FDA.reportPublic FDA data

NDC 17856-0646-4 - AMANTADINE HYDROCHLORIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
17856-0646
Requested NDC
17856-0646-4
Package NDCs from labels
17856-0646-3, 17856-0646-1, 17856-0646-4, 17856-0646-2
Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2025-05-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amantadine Hydrochloride Oral Solution USP 50 mg/5 mLATLANTIC BIOLOGICALS CORP.2025-05-12HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
17856-0646-12024-04-08Amantadine Hydrochloride Oral Solution USP 50 mg/5 mL
17856-0646-22024-04-08Amantadine Hydrochloride Oral Solution USP 50 mg/5 mL
17856-0646-12024-01-30Amantadine Hydrochloride Oral Solution USP 50 mg/5 mL
17856-0646-22024-01-30Amantadine Hydrochloride Oral Solution USP 50 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0646-1AMANTADINE HYDROCHLORIDE72 in 1 BOX, UNIT-DOSESOLUTION724
17856-0646-2AMANTADINE HYDROCHLORIDE72 in 1 PACKAGESOLUTION724
17856-0646-3AMANTADINE HYDROCHLORIDE10 mL in 1 CUP, UNIT-DOSESOLUTION104
17856-0646-4AMANTADINE HYDROCHLORIDE5 mL in 1 CUP, UNIT-DOSESOLUTION54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0646AMANTADINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.]4Current NDC, Legacy NDC, 4 package rows20250514_6311b46b-23cc-40c1-93c2-f7c92606386f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0646-1ML - Milliliter17856-0646131fab16-c40f-4017-b8e6-0450c9c3649f12025-06-13
17856-0646-2ML - Milliliter17856-06460f48881a-f29b-4b66-bb38-0ccada9cb37c12025-06-13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 8 of 19 · 366 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEBryant Ranch Prepack56b923c3-1d4a-47bf-9c9e-c0fdc54c8a2f2025-10-24Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
unii: 6DC9Q167V3
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEBryant Ranch Prepack96aefbca-fe71-42ef-8079-d0d9e7370ccb2025-10-22Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEBryant Ranch Prepacka10bf8b5-bf70-4090-b4b2-a0be252b9fe42025-10-22Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Ultra LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4533-2061-e063-6394a90a6e732025-10-17WarningsExact identifier
unii: 6DC9Q167V3
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dry eye reliefPOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADERf8da3af5-9172-4023-be82-0fd5bd8916162025-09-12WarningsExact identifier
unii: 6DC9Q167V3
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEMarlex Pharmaceuticals Inc25af52ee-9b29-4c07-a383-62d4537b63e02025-09-10Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY3dd7f2a6-5a91-81a2-e063-6294a90a33db2025-09-02Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Medique Medi SeltzerASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnifirst First Aid Corporation528da9d9-2a52-4c16-b7b2-61b3eee1abea2025-08-19WarningsExact identifier
unii: 2968PHW8QP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.