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 2 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEBryant Ranch Prepack6326d7f5-4c7c-4541-8db1-c582f1525f602026-04-15Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDECardinal Health 107, LLC5989098d-2855-4b5f-9a06-64a83656c0782026-04-08Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEZhejiang Jutai Pharmaceutical Co., Ltd.9c5e0c61-372b-4d1b-8882-e13f6af8fed02026-03-26Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Dynamic BrainARGENTUM NITRICUM, CUPRUM ACETICUM, GINKGO BILOBA, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, THIAMINUM HYDROCHLORICUM, CEREBRUM SUIS, AMBRA GRISEA, PICRICUM ACIDUM, AGNUS CASTUS, ALUMINA, ANACARDIUM ORIENTALE, BARYTA CARBONICA, CICUTA VIROSA, CONIUM MACULATUM, HELLEBORUS NIGER, PLUMBUM METALLICUM, SELENIUM METALLICUM, ZINCUM METALLICUMDeseret Biologicals, Inc.60a1e44b-3f91-41de-82c2-4648fb800dcd2026-03-19WarningsExact identifier
unii: LMI26O6933
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: LMI26O6933
Total Body DetoxALUMINA, BRYONIA, CALCAREA IODATA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MAR, CHELIDONIUM MAJ, CINCHONA OFFICINALIS, CYNARA SCOLYMUS, DIOSCOREA VILLOSA, HEPAR SULPHURIS CALCAREUM, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, KALI IODATUM, MERCURIUS CORROSIVUS, MERCURIUS VIVUS, NATRUM CARBONICUM, NUX VOMICA, PLUMBUM METALLICUM, PTELEA TRIFOLIATA, RICINUS COMMUNIS, ROBINIA PSEUDOACACIA, SERUM ANGUILLAE, SOLIDAGO VIRGAUREA, SULPHUR, SULPHURICUM ACIDUM AND TARAXACUM OFFICINALE.King Bio Inc.c803733e-b5e2-46f2-bdfe-b239f38d93122026-03-04WarningsExact identifier
unii: LMI26O6933
MERC CORRALUMINA, BRYONIA, COLOCYNTHIS, CHINA OFF, LYCOPODIUM, THUJA OCC, NUX VOMBM Private Limited3b29d70d-f291-dad2-e063-6294a90a07f52026-02-12WarningsExact identifier
unii: LMI26O6933
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E
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
AmantadineAMANTADINENCS HealthCare of KY, LLC dba Vangard Labs2ff05131-f634-4688-86e9-9bc33a8d11c42026-01-23Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
AmantadineAMANTADINEAvPAK48c949e3-86e0-c639-e063-6294a90acdba2026-01-19Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Amantadine HCLAMANTADINE HCLDirect RX487125c0-51e7-aea3-e063-6394a90a69302026-01-15Warnings, Adverse reactionsExact identifier
unii: M6Q1EO9TD0
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: LMI26O6933
Metex 6013METEXProfessional Complementary Health Formulas78371ca3-50a6-46f0-8ea6-7de57c5163752026-01-08WarningsExact identifier
unii: LMI26O6933

Reported adverse events (FAERS/openFDA)#

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