FDA.reportPublic FDA data

NDC 69097-925-07 - 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
69097-925
Requested NDC
69097-925-07
Package NDCs from labels
69097-925-07, 69097-925-12
Manufacturer
Cipla USA Inc. | suven life sciences | Moehs Catalana S.L
Effective date
2019-08-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMANTADINE - Cipla USA Inc. | suven life sciences | Moehs Catalana S.LCipla USA Inc. | suven life sciences | Moehs Catalana S.L2019-08-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-925-07EA - Each69097-92544a967a3-3fc3-428d-96d7-202498ef4e5912017-06-15
69097-925-12EA - Each69097-9256f0eb92e-7f3d-4454-af0c-6ae50fe7b93e12017-06-15

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 5 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
ColostatRHAMNUS PURSHIANA, SPIGELIA ANTHELMIA, TARAXACUM OFFICINALE, CAJUPUTUM, HYDRASTIS CANADENSIS, ALUMINA, CINA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, MANDRAGORA OFFICINARUM, NUX VOMICAEnergique, Inc.89c86e7b-304c-43a6-81e7-373d95c9fac12025-10-06WarningsExact identifier
unii: LMI26O6933
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: LMI26O6933
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEMarlex Pharmaceuticals Inc25af52ee-9b29-4c07-a383-62d4537b63e02025-09-10Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY3dd7f2a6-5a91-81a2-e063-6294a90a33db2025-09-02Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharmabe411327-5ac7-46df-b5e4-32a11b419b152025-08-07Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
AmantadineAMANTADINEAlembic Pharmaceuticals Inc.da1837b5-fda2-48e0-91ba-d6eb2b991b552025-07-28Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Rena-ChordHOMEOPATHIC LIQUIDEnergetix Corporation4071f90a-8a28-4338-810b-c9b18cf32f872025-07-15WarningsExact identifier
unii: LMI26O6933
amantadine hydrochlorideAMANTADINE HYDROCHLORIDEBryant Ranch Prepack8e578f11-6112-4a1f-8de4-a76870bb62c72025-07-14Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
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
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
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

Reported adverse events (FAERS/openFDA)#

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