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 4 of 19 · 366 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC.fd57a176-7faf-4053-b348-6ba5f192f05a2026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
unii: 6DC9Q167V3
AmantadineAMANTADINEProficient Rx LP7aa6bc18-1cee-4b6d-b7c3-0bac6a924ece2026-02-01Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEStrides Pharma Inc.e4d8f36f-d668-4728-8dca-b1c22bd9aedb2026-01-30Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
AmantadineAMANTADINENCS HealthCare of KY, LLC dba Vangard Labs2ff05131-f634-4688-86e9-9bc33a8d11c42026-01-23Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AmantadineAMANTADINEAvPAK48c949e3-86e0-c639-e063-6294a90acdba2026-01-19Warnings, Adverse reactionsExact identifier
rxcui: 849385
unii: M6Q1EO9TD0
SWISS BLEU Relief-Calm Antimicrobial Skin CreamLACTOBACILLUS FERMENT LYSATE, LEONTOPODIUM ALPINUM, CALENDULA OFFICINALIS FLOWER EXTRACT, EVENING PRIMROSE FLOWER EXTRACT, CITRIC ACIDNanjing Hongruixing Biological Technology Co., Ltd487d3c2c-ce28-f7a1-e063-6294a90a5ec62026-01-16WarningsExact identifier
unii: 2968PHW8QP
Amantadine HCLAMANTADINE HCLDirect RX487125c0-51e7-aea3-e063-6394a90a69302026-01-15Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
unii: 6DC9Q167V3
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEMajor Pharmaceuticalsb2f7da34-ad78-4db3-9af1-bdd341e09f162026-01-05Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
GeriCare Sorbitol SolutionSORBITOLGERI-CARE PHARMACEUTICALS, CORPb4dd7a41-380e-d94b-e053-2a95a90ac34a2025-12-31WarningsExact identifier
unii: 506T60A25R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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