gloperba

Generic: colchicine

Labeler: scilex pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gloperba
Generic Name colchicine
Labeler scilex pharmaceuticals inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

colchicine .6 mg/5mL

Manufacturer
Scilex Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 69557-222
Product ID 69557-222_25e07ab6-c140-6aae-e063-6394a90ac06e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210942
Listing Expiration 2026-12-31
Marketing Start 2024-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69557222
Hyphenated Format 69557-222

Supplemental Identifiers

RxCUI
2118892 2180558
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 gloperba (source: ndc)
Generic Name colchicine (source: ndc)
Application Number NDA210942 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .6 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69557-222-01) / 150 mL in 1 BOTTLE
source: ndc

Packages (1)

69557-222-01 1 BOTTLE in 1 CARTON (69557-222-01) / 150 mL in 1 BOTTLE

Ingredients (1)

colchicine (.6 mg/5mL)

Linked Drug Pages (1)

Gloperba ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "25e07ab6-c140-6aae-e063-6394a90ac06e", "openfda": {"nui": ["N0000193949", "M0000713"], "unii": ["SML2Y3J35T"], "rxcui": ["2118892", "2180558"], "spl_set_id": ["467cd83f-d695-4040-9434-10e80b4271da"], "pharm_class_cs": ["Alkaloids [CS]"], "pharm_class_epc": ["Alkaloid [EPC]"], "manufacturer_name": ["Scilex Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69557-222-01)  / 150 mL in 1 BOTTLE", "package_ndc": "69557-222-01", "marketing_start_date": "20240131"}], "brand_name": "Gloperba", "product_id": "69557-222_25e07ab6-c140-6aae-e063-6394a90ac06e", "dosage_form": "SOLUTION", "pharm_class": ["Alkaloid [EPC]", "Alkaloids [CS]"], "product_ndc": "69557-222", "generic_name": "Colchicine", "labeler_name": "Scilex Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gloperba", "active_ingredients": [{"name": "COLCHICINE", "strength": ".6 mg/5mL"}], "application_number": "NDA210942", "marketing_category": "NDA", "marketing_start_date": "20240131", "listing_expiration_date": "20261231"}