galantamine hydrobromide

Generic: galantamine hydrobromide

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name galantamine hydrobromide
Generic Name galantamine hydrobromide
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

galantamine hydrobromide 24 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-837
Product ID 47335-837_3ddec6e9-e082-4c2d-a026-aee87736ef80
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090178
Listing Expiration 2026-12-31
Marketing Start 2011-02-09

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335837
Hyphenated Format 47335-837

Supplemental Identifiers

RxCUI
860695 860707 860715
UPC
0347335835830
UNII
MJ4PTD2VVW

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 galantamine hydrobromide (source: ndc)
Generic Name galantamine hydrobromide (source: ndc)
Application Number ANDA090178 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 24 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-837-08)
  • 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-837-18)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-837-83)
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-837-88)
source: ndc

Packages (4)

47335-837-08 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-837-08) 47335-837-18 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-837-18) 47335-837-83 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-837-83) 47335-837-88 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-837-88)

Ingredients (1)

galantamine hydrobromide (24 mg/1)

Linked Drug Pages (1)

Galantamine Hydrobromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3ddec6e9-e082-4c2d-a026-aee87736ef80", "openfda": {"upc": ["0347335835830"], "unii": ["MJ4PTD2VVW"], "rxcui": ["860695", "860707", "860715"], "spl_set_id": ["d1697161-ebe8-42b0-83e7-c9de4412546c"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-837-08)", "package_ndc": "47335-837-08", "marketing_start_date": "20110209"}, {"sample": false, "description": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-837-18)", "package_ndc": "47335-837-18", "marketing_start_date": "20110209"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-837-83)", "package_ndc": "47335-837-83", "marketing_start_date": "20110209"}, {"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-837-88)", "package_ndc": "47335-837-88", "marketing_start_date": "20110209"}], "brand_name": "Galantamine Hydrobromide", "product_id": "47335-837_3ddec6e9-e082-4c2d-a026-aee87736ef80", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "47335-837", "generic_name": "Galantamine Hydrobromide", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Galantamine Hydrobromide", "active_ingredients": [{"name": "GALANTAMINE HYDROBROMIDE", "strength": "24 mg/1"}], "application_number": "ANDA090178", "marketing_category": "ANDA", "marketing_start_date": "20110209", "listing_expiration_date": "20261231"}