colchicine

Generic: colchicine

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

Drug Facts

Product Profile

Brand Name colchicine
Generic Name colchicine
Labeler strides pharma science limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

colchicine .6 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-796
Product ID 64380-796_8de9440c-7d34-4837-8bdf-b31d84dff43a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209173
Listing Expiration 2027-12-31
Marketing Start 2022-09-19

Pharmacologic Class

Established (EPC)
alkaloid [epc]
Chemical Structure
alkaloids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380796
Hyphenated Format 64380-796

Supplemental Identifiers

RxCUI
197541
UPC
0364380796046 0364380796060
UNII
SML2Y3J35T
NUI
N0000193949 M0000713

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 colchicine (source: ndc)
Generic Name colchicine (source: ndc)
Application Number ANDA209173 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .6 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-796-04)
  • 100 TABLET, FILM COATED in 1 BOTTLE (64380-796-06)
source: ndc

Packages (2)

64380-796-04 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-796-04) 64380-796-06 100 TABLET, FILM COATED in 1 BOTTLE (64380-796-06)

Ingredients (1)

colchicine (.6 mg/1)

Linked Drug Pages (1)

Colchicine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8de9440c-7d34-4837-8bdf-b31d84dff43a", "openfda": {"nui": ["N0000193949", "M0000713"], "upc": ["0364380796046", "0364380796060"], "unii": ["SML2Y3J35T"], "rxcui": ["197541"], "spl_set_id": ["50b9c910-49a3-4a57-80f5-dc36c09da4df"], "pharm_class_cs": ["Alkaloids [CS]"], "pharm_class_epc": ["Alkaloid [EPC]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-796-04)", "package_ndc": "64380-796-04", "marketing_start_date": "20220919"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (64380-796-06)", "package_ndc": "64380-796-06", "marketing_start_date": "20220919"}], "brand_name": "Colchicine", "product_id": "64380-796_8de9440c-7d34-4837-8bdf-b31d84dff43a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Alkaloid [EPC]", "Alkaloids [CS]"], "product_ndc": "64380-796", "generic_name": "Colchicine", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colchicine", "active_ingredients": [{"name": "COLCHICINE", "strength": ".6 mg/1"}], "application_number": "ANDA209173", "marketing_category": "ANDA", "marketing_start_date": "20220919", "listing_expiration_date": "20271231"}