memantine hydrochloride

Generic: memantine hydrochloride

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler zydus pharmaceuticals usa inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

memantine hydrochloride 7 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-546
Product ID 68382-546_079cb172-4d62-4571-98b9-5ad01706dbee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203293
Listing Expiration 2026-12-31
Marketing Start 2018-04-08

Pharmacologic Class

Classes
n-methyl-d-aspartate receptor antagonist [epc] nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382546
Hyphenated Format 68382-546

Supplemental Identifiers

RxCUI
996594 996603 996609 996615
UPC
0368382548061
UNII
JY0WD0UA60

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name memantine hydrochloride (source: ndc)
Generic Name memantine hydrochloride (source: ndc)
Application Number ANDA203293 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-546-06)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-546-16)
  • 10 BLISTER PACK in 1 CARTON (68382-546-77) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-546-30)
source: ndc

Packages (3)

68382-546-06 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-546-06) 68382-546-16 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-546-16) 68382-546-77 10 BLISTER PACK in 1 CARTON (68382-546-77) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-546-30)

Ingredients (1)

memantine hydrochloride (7 mg/1)

Linked Drug Pages (1)

Memantine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "079cb172-4d62-4571-98b9-5ad01706dbee", "openfda": {"upc": ["0368382548061"], "unii": ["JY0WD0UA60"], "rxcui": ["996594", "996603", "996609", "996615"], "spl_set_id": ["eac265e6-6ea4-4368-acff-2efe6a8dd40a"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-546-06)", "package_ndc": "68382-546-06", "marketing_start_date": "20180408"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-546-16)", "package_ndc": "68382-546-16", "marketing_start_date": "20180408"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-546-77)  / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-546-30)", "package_ndc": "68382-546-77", "marketing_start_date": "20180408"}], "brand_name": "Memantine hydrochloride", "product_id": "68382-546_079cb172-4d62-4571-98b9-5ad01706dbee", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "68382-546", "generic_name": "Memantine hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "7 mg/1"}], "application_number": "ANDA203293", "marketing_category": "ANDA", "marketing_start_date": "20180408", "listing_expiration_date": "20261231"}