celecoxib

Generic: celecoxib

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name celecoxib
Generic Name celecoxib
Labeler apotex corp.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

celecoxib 200 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-3849
Product ID 60505-3849_a85a8c84-9b0b-7064-bc41-1022e2fbdb41
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204197
Marketing Start 2015-06-03
Marketing End 2027-01-31

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605053849
Hyphenated Format 60505-3849

Supplemental Identifiers

RxCUI
205322 205323 686379
UNII
JCX84Q7J1L
NUI
N0000000160 M0001335 N0000175722

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 celecoxib (source: ndc)
Generic Name celecoxib (source: ndc)
Application Number ANDA204197 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (60505-3849-1)
  • 500 CAPSULE in 1 BOTTLE (60505-3849-5)
source: ndc

Packages (2)

60505-3849-1 100 CAPSULE in 1 BOTTLE (60505-3849-1) 60505-3849-5 500 CAPSULE in 1 BOTTLE (60505-3849-5)

Ingredients (1)

celecoxib (200 mg/1)

Linked Drug Pages (1)

Celecoxib ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a85a8c84-9b0b-7064-bc41-1022e2fbdb41", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["JCX84Q7J1L"], "rxcui": ["205322", "205323", "686379"], "spl_set_id": ["a62612b3-9564-2b34-be59-6aa5ac53679c"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (60505-3849-1)", "package_ndc": "60505-3849-1", "marketing_end_date": "20270131", "marketing_start_date": "20150603"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (60505-3849-5)", "package_ndc": "60505-3849-5", "marketing_end_date": "20270131", "marketing_start_date": "20150603"}], "brand_name": "Celecoxib", "product_id": "60505-3849_a85a8c84-9b0b-7064-bc41-1022e2fbdb41", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "60505-3849", "generic_name": "Celecoxib", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Celecoxib", "active_ingredients": [{"name": "CELECOXIB", "strength": "200 mg/1"}], "application_number": "ANDA204197", "marketing_category": "ANDA", "marketing_end_date": "20270131", "marketing_start_date": "20150603"}