galantamine

Generic: galantamine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name galantamine
Generic Name galantamine
Labeler aurobindo pharma limited
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

galantamine hydrobromide 8 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-744
Product ID 65862-744_5b352114-093a-450c-81d1-4914dac5e2e3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204895
Listing Expiration 2026-12-31
Marketing Start 2016-08-05

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862744
Hyphenated Format 65862-744

Supplemental Identifiers

RxCUI
860695 860707 860715
UPC
0365862744302 0365862746306 0365862745309
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 (source: ndc)
Generic Name galantamine (source: ndc)
Application Number ANDA204895 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-01)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-05)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-30)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-90)
  • 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-99)
source: ndc

Packages (5)

65862-744-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-01) 65862-744-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-05) 65862-744-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-30) 65862-744-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-90) 65862-744-99 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-99)

Ingredients (1)

galantamine hydrobromide (8 mg/1)

Linked Drug Pages (1)

Galantamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5b352114-093a-450c-81d1-4914dac5e2e3", "openfda": {"upc": ["0365862744302", "0365862746306", "0365862745309"], "unii": ["MJ4PTD2VVW"], "rxcui": ["860695", "860707", "860715"], "spl_set_id": ["d0b75970-8d3d-408b-9e17-9cbad0f776b1"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-01)", "package_ndc": "65862-744-01", "marketing_start_date": "20160805"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-05)", "package_ndc": "65862-744-05", "marketing_start_date": "20160805"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-30)", "package_ndc": "65862-744-30", "marketing_start_date": "20160805"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-90)", "package_ndc": "65862-744-90", "marketing_start_date": "20160805"}, {"sample": false, "description": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-744-99)", "package_ndc": "65862-744-99", "marketing_start_date": "20160805"}], "brand_name": "Galantamine", "product_id": "65862-744_5b352114-093a-450c-81d1-4914dac5e2e3", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "65862-744", "generic_name": "Galantamine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Galantamine", "active_ingredients": [{"name": "GALANTAMINE HYDROBROMIDE", "strength": "8 mg/1"}], "application_number": "ANDA204895", "marketing_category": "ANDA", "marketing_start_date": "20160805", "listing_expiration_date": "20261231"}