colchicine

Generic: colchicine

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

Drug Facts

Product Profile

Brand Name colchicine
Generic Name colchicine
Labeler granules pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

colchicine .6 mg/1

Manufacturer
Granules Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 70010-002
Product ID 70010-002_018d4e2e-c594-17cf-e063-6294a90a7bb2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210425
Listing Expiration 2026-12-31
Marketing Start 2020-05-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70010002
Hyphenated Format 70010-002

Supplemental Identifiers

RxCUI
197541
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 ANDA210425 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .6 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (70010-002-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (70010-002-03)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (70010-002-10)
source: ndc

Packages (3)

70010-002-01 100 TABLET, FILM COATED in 1 BOTTLE (70010-002-01) 70010-002-03 30 TABLET, FILM COATED in 1 BOTTLE (70010-002-03) 70010-002-10 1000 TABLET, FILM COATED in 1 BOTTLE (70010-002-10)

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": "018d4e2e-c594-17cf-e063-6294a90a7bb2", "openfda": {"nui": ["N0000193949", "M0000713"], "unii": ["SML2Y3J35T"], "rxcui": ["197541"], "spl_set_id": ["dcf97364-b35f-4bc9-8a92-d3d2e05f47ac"], "pharm_class_cs": ["Alkaloids [CS]"], "pharm_class_epc": ["Alkaloid [EPC]"], "manufacturer_name": ["Granules Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (70010-002-01)", "package_ndc": "70010-002-01", "marketing_start_date": "20200513"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70010-002-03)", "package_ndc": "70010-002-03", "marketing_start_date": "20200513"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (70010-002-10)", "package_ndc": "70010-002-10", "marketing_start_date": "20230513"}], "brand_name": "Colchicine", "product_id": "70010-002_018d4e2e-c594-17cf-e063-6294a90a7bb2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Alkaloid [EPC]", "Alkaloids [CS]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Interactions [MoA]"], "product_ndc": "70010-002", "generic_name": "Colchicine", "labeler_name": "Granules Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colchicine", "active_ingredients": [{"name": "COLCHICINE", "strength": ".6 mg/1"}], "application_number": "ANDA210425", "marketing_category": "ANDA", "marketing_start_date": "20200513", "listing_expiration_date": "20261231"}