Amantadine Hydrochloride

Product NDC: 0781-2048
11-digit product format: 007812048
Labeler code: 0781
Product ID: 0781-2048_5bb21b3b-b876-4d94-9353-9aa53bb2a7f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amantadine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA071293
Marketing category: ANDA
Marketing start: 1987-02-18
Marketing end: 0000-00-00
Substance: AMANTADINE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
519d6abc-639d-2962-cced-abbf8b16aad4	Product name	7	20250401
82f46845-b4c7-48da-a389-ba5721b956c9	Product name	2	20250325
d2c037c0-5ebf-d224-252f-2549922c21c7	Product name	7	20240208
b7b57a62-2f7f-1a22-2cb2-eaa5c08d4721	Product name	2	20220224
14e11aaf-885f-472f-a02a-c6a3f28df907	Product name	1	20180515
82f46845-b4c7-48da-a389-ba5721b956c9	Product name	1	20171103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-2048-01	EA - Each	0781-2048	7b73f912-810f-4a4b-b456-b025ff51d872	1	2012-07-24
0781-2048-05	EA - Each	0781-2048	087053a1-a21b-4c71-a77e-2f514f4f8dfd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMANTADINE HYDROCHLORIDE	ACTIVE INGREDIENT	M6Q1EO9TD0	AMANTADINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	5
AMANTADINE	ACTIVE MOIETY	BF4C9Z1J53	AMANTADINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMANTADINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AMANTADINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	5
ETHYLCELLULOSE (7 MPA.S)	INACTIVE INGREDIENT	H3UP11403C	AMANTADINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMANTADINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMANTADINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMANTADINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMANTADINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	AMANTADINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	AMANTADINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMANTADINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMANTADINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMANTADINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	5
AMANTADINE HYDROCHLORIDE	ACTIVE INGREDIENT	M6Q1EO9TD0	AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
AMANTADINE	ACTIVE MOIETY	BF4C9Z1J53	AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
ETHYLCELLULOSE (7 MPA.S)	INACTIVE INGREDIENT	H3UP11403C	AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMANTADINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
AMANTADINE HYDROCHLORIDE	ACTIVE INGREDIENT	M6Q1EO9TD0	AMANTADINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
AMANTADINE HYDROCHLORIDE	ACTIVE INGREDIENT	M6Q1EO9TD0	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
AMANTADINE HYDROCHLORIDE	ACTIVE INGREDIENT	M6Q1EO9TD0	AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
AMANTADINE HYDROCHLORIDE	ACTIVE INGREDIENT	M6Q1EO9TD0	AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
AMANTADINE	ACTIVE MOIETY	BF4C9Z1J53	AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
AMANTADINE	ACTIVE MOIETY	BF4C9Z1J53	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
AMANTADINE	ACTIVE MOIETY	BF4C9Z1J53	AMANTADINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
AMANTADINE	ACTIVE MOIETY	BF4C9Z1J53	AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMANTADINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AMANTADINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
ETHYLCELLULOSE (7 MPA.S)	INACTIVE INGREDIENT	H3UP11403C	AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
ETHYLCELLULOSE (7 MPA.S)	INACTIVE INGREDIENT	H3UP11403C	AMANTADINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
ETHYLCELLULOSE (7 MPA.S)	INACTIVE INGREDIENT	H3UP11403C	AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
ETHYLCELLULOSE (7 MPA.S)	INACTIVE INGREDIENT	H3UP11403C	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMANTADINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMANTADINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMANTADINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMANTADINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	AMANTADINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	AMANTADINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMANTADINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMANTADINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMANTADINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMANTADINE HYDROCHLORIDE CAPSULE [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMANTADINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M6Q1EO9TD0	AMANTADINE HYDROCHLORIDE	665-66-7	AMANTADINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
849389	amantadine HCl 100 MG Oral Capsule	PSN	da693bb0-0cc8-485d-89a7-c8cf28d440f3	8
849389	amantadine hydrochloride 100 MG Oral Capsule	SCD	da693bb0-0cc8-485d-89a7-c8cf28d440f3	8
849389	amantadine HCl 100 MG Oral Capsule	PSN	33a3e25d-80fa-479f-a419-d9487281deff	5
849389	amantadine hydrochloride 100 MG Oral Capsule	SCD	33a3e25d-80fa-479f-a419-d9487281deff	5
849389	amantadine HCl 100 MG Oral Capsule	PSN	076740b2-9a76-45e9-9d56-87e9f3b96e97	3
849389	amantadine hydrochloride 100 MG Oral Capsule	SCD	076740b2-9a76-45e9-9d56-87e9f3b96e97	3
849389	amantadine HCl 100 MG Oral Capsule	PSN	0637f133-1f9d-48b3-b82f-a4e16f926cd6	1
849389	amantadine HCl 100 MG Oral Capsule	PSN	99351f6a-82d7-4d3b-a214-e48260a63d05	1
849389	amantadine HCl 100 MG Oral Capsule	PSN	c40ecd11-0b6e-4f13-bfba-8f011c60ca16	1
849389	amantadine hydrochloride 100 MG Oral Capsule	SCD	0637f133-1f9d-48b3-b82f-a4e16f926cd6	1
849389	amantadine hydrochloride 100 MG Oral Capsule	SCD	99351f6a-82d7-4d3b-a214-e48260a63d05	1
849389	amantadine hydrochloride 100 MG Oral Capsule	SCD	c40ecd11-0b6e-4f13-bfba-8f011c60ca16	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amantadine Hydrochloride Capsules, USP Rx only	A-S Medication Solutions	2026-05-15	HUMAN PRESCRIPTION DRUG LABEL	8
Amantadine Hydrochloride Capsules, USP	Carilion Materials Management	2016-08-04	HUMAN PRESCRIPTION DRUG LABEL	3
Amantadine Hydrochloride Capsules, USP	Aphena Pharma Solutions - Tennessee, LLC	2014-06-10	HUMAN PRESCRIPTION DRUG LABEL	1
Amantadine Hydrochloride Capsules, USP	Physicians Total Care, Inc.	2014-01-17	HUMAN PRESCRIPTION DRUG LABEL	5
Amantadine Hydrochloride Capsules, USP	Aidarex Pharmaceuticals LLC	2013-11-15	HUMAN PRESCRIPTION DRUG LABEL	1
Amantadine Hydrochloride Capsules, USP	STAT RX USA LLC	2010-09-16	HUMAN PRESCRIPTION DRUG LABEL	1

Amantadine Hydrochloride

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Related DailyMed Labels#