NDC 0832-0111-89 - 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: 0832-0111
Requested NDC: 0832-0111-89
Package NDCs from labels: 0832-0111-00, 0832-0111-50, 0832-0111-89, 0832-0111-03
Manufacturer: Upsher-Smith Laboratories, LLC | BORA Pharmaceuticals, Inc.
Effective date: 2025-12-11
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Amantadine Hydrochloride Tablets, USP	Upsher-Smith Laboratories, LLC \| BORA Pharmaceuticals, Inc.	2025-12-11	HUMAN PRESCRIPTION DRUG LABEL
Amantadine Hydrochloride Tablets, USP	REMEDYREPACK INC.	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0832-0111-00	Amantadine Hydrochloride	100 in 1 BOTTLE	TABLET	100	11
0832-0111-03	Amantadine Hydrochloride	100 in 1 CARTON	TABLET	100	11
0832-0111-50	Amantadine Hydrochloride	500 in 1 BOTTLE	TABLET	500	11
0832-0111-89	Amantadine Hydrochloride	1 in 1 BLISTER PACK	TABLET	1	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0832-0111	AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, LLC]	8	Current NDC, Legacy NDC, 4 package rows	20230519_63d9d4aa-5f92-45b0-98d0-d6ec38b727cb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0832-0111-00	EA - Each	0832-0111	ab567895-32cf-4caa-8bf0-d7e2d215a311	1	2012-07-24
0832-0111-03	EA - Each	0832-0111	b5e124ee-ca83-46f4-9318-ebe37de65335	1	2017-08-11
0832-0111-50	EA - Each	0832-0111	10caabf1-f551-4977-bea9-b997beca8dab	1	2012-07-24
0832-0111-89	EA - Each	0832-0111	812c6bd3-9c38-4702-9416-3fc98c72c985	1	2017-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
amantadine hydrochloride	ACTIVE INGREDIENT	M6Q1EO9TD0	AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]	3
amantadine	ACTIVE MOIETY	BF4C9Z1J53	AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]	3
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]	3
STARCH, POTATO	INACTIVE INGREDIENT	8I089SAH3T	AMANTADINE HYDROCHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC]	3

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 12 of 39 · 768 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Discount Drug Mart Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Discount Drug Mart, Inc.	f75c2f84-a28c-5807-e053-6294a90a2295	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Exchange Select Eye Drops Advanced Relief Moisturizer	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Army and Air Force Exchange Service	9e475240-2df1-9bee-e053-2995a90a8d4b	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Family Wellness Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Family Dollar Services, Inc.	facd329b-1923-61df-e053-6294a90ab738	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
DG Health Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Dolgencorp LLC	9c62f8a3-7cf5-40f9-e053-2a95a90afd86	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	KC Pharmaceuticals, Inc.	eb6eb6c4-1609-407b-84e4-c7509811f3c0	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Medics Choice Eye Drops Advanced	TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE	KC Pharmaceuticals, Inc.	ab906fd8-265c-4359-a920-d626366e245c	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Publix Artificial Tears Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Publix Super Markets, Inc.	f5d1394b-0fe8-c372-e053-2a95a90a1f78	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Best Choice Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Best Choice	f5ba63f3-7966-81fe-e053-2995a90a342c	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Publix Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Publix Super Markets, Inc.	f7b0c3d6-0324-46c3-e053-6394a90a8241	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Kroger Eye Drops Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	The Kroger Company	f76f08c5-0111-8bc5-e053-6294a90a16ee	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Core Values Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Liberty Procurement Co., Inc.	f76dfeca-4e86-0b5d-e053-6294a90a29b9	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Best Choice Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Valu Merchandisers, Co.	f7491a17-8035-5a3c-e053-6294a90a615c	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Winco Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	WinCo Foods, LLC	f10778c8-14fe-4852-8b73-42db502fd2bc	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Harris Teeter Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Harris Teeter, LLC	f76e2831-5c6c-7a62-e053-6294a90a937b	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
CareOne Artificial Tears Eye Drops 15mL	POLYVINYL ALCOHOL, POVIDONE	Retail Business Services, LLC	92fded6b-91fd-d82e-e053-2a95a90ab523	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Quality Choice Artificial Tears Lubricant Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Chain Drug Marketing Association, Inc.	1f669655-4bc7-0175-e063-6294a90a305a	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Equate Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Walmart, Inc.	ead9f271-0f15-1fff-e053-2a95a90a93ac	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Eye Love Heyedrate Long Lasting Hydration	GLYCERIN, POVIDONE	Physician Recommended Neutraceuticals, L.P.	f321dea1-3251-eaa8-e053-2995a90aaf95	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
Quality Choice Moisturizing Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Chain Drug Marketing Association, Inc.	1fb81759-5931-59c8-e063-6294a90a2277	2025-12-30	Warnings	Exact identifier unii: FZ989GH94E
StellaLife VEGA Oral Care	SPRAY	StellaLife, Inc.	b8ba495e-2cfe-092c-e053-2995a90a3fd3	2025-12-24	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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