Amantadine Hydrochloride

Product NDC: 71335-2959
11-digit product format: 713352959
Labeler code: 71335
Product ID: 71335-2959_99e43d39-01e6-445c-a222-78b4fb8b5cd3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amantadine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA209171
Marketing category: ANDA
Marketing start: 2017-06-12
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: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 71335-2959_99e43d39-01e6-445c-a222-78b4fb8b5cd3
SPL ID: 99e43d39-01e6-445c-a222-78b4fb8b5cd3
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Amantadine Hydrochloride
Generic name: Amantadine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Marketing start: 2017-06-12
Marketing category: ANDA
Application number: ANDA209171
Pharmacologic classes: Influenza A M2 Protein Inhibitor [EPC]; M2 Protein Inhibitors [MoA]
Listing expiration: 2026-12-31

Ingredient	Strength
AMANTADINE HYDROCHLORIDE	100 mg/1

Package NDC	Description	Marketing start	Sample
71335-2959-1	100 CAPSULE in 1 BOTTLE (71335-2959-1)	2025-10-22	No

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

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2959-1	71335295901	100 CAPSULE in 1 BOTTLE (71335-2959-1)	100 capsule	2025-10-22	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Rx only	Bryant Ranch Prepack	2025-10-22	HUMAN PRESCRIPTION DRUG LABEL	100