Memantine Hydrochloride

Product NDC: 63629-2511
11-digit product format: 636292511
Labeler code: 63629
Product ID: 63629-2511_14b17a3c-b3e8-41e3-b0e0-664225c6373f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Memantine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA090961
Marketing category: ANDA
Marketing start: 2019-02-28
Substance: MEMANTINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 63629-2511_14b17a3c-b3e8-41e3-b0e0-664225c6373f
SPL ID: 14b17a3c-b3e8-41e3-b0e0-664225c6373f
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Memantine Hydrochloride
Generic name: Memantine Hydrochloride
Dosage form: TABLET
Route: ORAL
Marketing start: 2019-02-28
Marketing category: ANDA
Application number: ANDA090961
Pharmacologic classes: N-methyl-D-aspartate Receptor Antagonist [EPC]; NMDA Receptor Antagonists [MoA]
Listing expiration: 2026-12-31

Ingredient	Strength
MEMANTINE HYDROCHLORIDE	10 mg/1

Package NDC	Description	Marketing start	Sample
63629-2511-1	500 TABLET in 1 BOTTLE (63629-2511-1)	2021-05-18	No

UNII	Preferred term	Registry number	Matched term
JY0WD0UA60	MEMANTINE HYDROCHLORIDE	41100-52-1	MEMANTINE HYDROCHLORIDE

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63629-2511-1	63629251101	500 TABLET in 1 BOTTLE (63629-2511-1)	500 tablet	2021-05-18	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Memantine Hydrochloride	Bryant Ranch Prepack	2023-03-03	HUMAN PRESCRIPTION DRUG LABEL	102