FDA.reportPublic FDA data

NDC 73309-063 - 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
73309-063
Package NDCs from labels
73309-063-01
Manufacturer
BLUEBAY SHANDONG CO.,LTD
Effective date
2019-12-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amantadine Hydrochloride - BLUEBAY SHANDONG CO.,LTDBLUEBAY SHANDONG CO.,LTD2019-12-02BULK INGREDIENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73309-063-01Amantadine Hydrochloride500 g in 1 JARPOWDER5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73309-063AMANTADINE HYDROCHLORIDE POWDER [BLUEBAY SHANDONG CO.,LTD]11 package rows20191203_33011d3d-645f-47fd-a856-1ba2bce0cca2.zip

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 3 of 3 · 55 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDECoupler LLC2d94073b-c064-c280-e063-6294a90af1452025-02-07Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEProficient Rx LPa3810649-1301-4332-85df-722b36867b1b2025-02-01Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
amantadine hydrochlorideAMANTADINE HYDROCHLORIDECoupler LLC2cb6e83d-e635-b150-e063-6294a90ad61d2025-01-27Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HCLAMANTADINE HCLDirect_Rxf28c55c8-2754-a44d-e053-2a95a90ae7982025-01-22Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEBryant Ranch Prepack1f3c7c37-c488-4a88-8251-7db52dc038272024-11-04Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEChartwell RX, LLCa016ab57-d18f-4a3b-b2ab-f91fecc1eef72024-10-10Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsb54064bc-b3e1-4d83-be40-fcaddd2e99d02024-08-05Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEPatrin Pharma, Inc.0fcf5182-a666-4f38-879f-47f19de30dd52024-05-20Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HCLAMANTADINE HCLDirect_Rx1211ebf4-3169-20ca-e063-6294a90aee4d2024-02-29Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEAmerican Health Packaging5a8f16cc-e5d5-4097-8297-10c8166c7a0e2024-02-21Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEStrides Pharma Science Limited20dad861-6ad1-4660-b315-8af57b2941752023-07-17Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
AmantadineAMANTADINEAlembic Pharmaceuticals Limited48fa07c8-8b95-40d7-a0f5-132577dfb2c82023-01-27Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
amantadineAMANTADINEAlembic Pharmaceuticals Limitedd8887814-3e56-447e-8bc3-add1861e0cf72023-01-27Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
amantadine hydrochlorideAMANTADINE HYDROCHLORIDEProficient Rx LP743d1b73-f47e-4bbf-bb52-45b1e7f173082022-09-01Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEProficient Rx LPf0e9b795-c0a1-4c95-928c-dacaaf9b3bb52019-10-01Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0

Reported adverse events (FAERS/openFDA)#

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