celecoxib

Generic: celecoxib

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name celecoxib
Generic Name celecoxib
Labeler major pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

celecoxib 200 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6503
Product ID 0904-6503_945b6833-914c-4ec8-a9fa-2384b6483ea9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204197
Marketing Start 2015-06-25
Marketing End 2026-06-30

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 09046503
Hyphenated Format 0904-6503

Supplemental Identifiers

RxCUI
205322 205323
UNII
JCX84Q7J1L
NUI
N0000000160 M0001335 N0000175722

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 BLISTER PACK in 1 CARTON (0904-6503-61) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6503-61 100 BLISTER PACK in 1 CARTON (0904-6503-61) / 1 CAPSULE in 1 BLISTER PACK

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": "945b6833-914c-4ec8-a9fa-2384b6483ea9", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["JCX84Q7J1L"], "rxcui": ["205322", "205323"], "spl_set_id": ["370b2bb0-8fb7-4e42-8ec4-e14bae2c4a46"], "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": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6503-61)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-6503-61", "marketing_end_date": "20260630", "marketing_start_date": "20150625"}], "brand_name": "Celecoxib", "product_id": "0904-6503_945b6833-914c-4ec8-a9fa-2384b6483ea9", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0904-6503", "generic_name": "Celecoxib", "labeler_name": "Major Pharmaceuticals", "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": "20260630", "marketing_start_date": "20150625"}