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 9 of 19 · 366 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharmabe411327-5ac7-46df-b5e4-32a11b419b152025-08-07Warnings, Adverse reactionsExact identifier
application number: ANDA074509
ndc (product): 0121-0646
rxcui: 849385
spl id: 0d5911e6-e5b6-4013-98ec-773d9ec62dec
spl set id: be411327-5ac7-46df-b5e4-32a11b419b15
unii: M6Q1EO9TD0
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
unii: 6DC9Q167V3
AmantadineAMANTADINEAlembic Pharmaceuticals Inc.da1837b5-fda2-48e0-91ba-d6eb2b991b552025-07-28Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
amantadine hydrochlorideAMANTADINE HYDROCHLORIDEBryant Ranch Prepack8e578f11-6112-4a1f-8de4-a76870bb62c72025-07-14Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEAdvagen Pharma Limitedc3b9e7f0-be6d-4f37-9277-54bb0ba8b1582025-07-09Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEUpsher-Smith Laboratories, LLC5232b933-1df9-43b4-8ac2-61bfa4855e682025-07-09Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEBAJAJ MEDICAL, LLC38fccce5-1f1e-9350-e063-6394a90a045a2025-07-02Warnings, Adverse reactionsExact identifier
rxcui: 849385
unii: M6Q1EO9TD0
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEBryant Ranch Prepacke3eb34af-6e25-4a3d-a7d2-e9a789e335cc2025-06-26Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HClAMANTADINE HYDROCHLORIDEAvPAK461e6444-189e-62ed-6c61-1c36a04459c62025-06-24Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HClAMANTADINE HYDROCHLORIDEAvKAREbfd129ae-8b0a-f118-b7d0-45d106290b632025-06-24Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
unii: 506T60A25R
Amantadine HClAMANTADINE HYDROCHLORIDEBionpharma Inc.d6ca4d20-72c5-496c-9ac7-1f5cb407a7422025-06-09Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
amantadine hydrochlorideAMANTADINE HYDROCHLORIDEEPIC PHARMA LLC0f70c79a-92a4-4a38-bbdd-900adc4c2e932025-06-06Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1b9498b7-125e-4314-baca-b62af6e5511c2025-06-06Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0

Reported adverse events (FAERS/openFDA)#

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