celecoxib

Generic: celecoxib

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name celecoxib
Generic Name celecoxib
Labeler quallent pharmaceuticals health llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

celecoxib 200 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-069
Product ID 82009-069_6ff0eca0-424c-44fb-9870-4f3d78b5559d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207446
Listing Expiration 2026-12-31
Marketing Start 2023-09-28

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 82009069
Hyphenated Format 82009-069

Supplemental Identifiers

RxCUI
205322 205323
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 ANDA207446 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (82009-069-05)
source: ndc

Packages (1)

82009-069-05 500 CAPSULE in 1 BOTTLE (82009-069-05)

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": "6ff0eca0-424c-44fb-9870-4f3d78b5559d", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["JCX84Q7J1L"], "rxcui": ["205322", "205323"], "spl_set_id": ["aaa3a4f5-b281-415f-a08c-e0cefdae2fb5"], "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": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (82009-069-05)", "package_ndc": "82009-069-05", "marketing_start_date": "20230928"}], "brand_name": "CELECOXIB", "product_id": "82009-069_6ff0eca0-424c-44fb-9870-4f3d78b5559d", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "82009-069", "generic_name": "CELECOXIB", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CELECOXIB", "active_ingredients": [{"name": "CELECOXIB", "strength": "200 mg/1"}], "application_number": "ANDA207446", "marketing_category": "ANDA", "marketing_start_date": "20230928", "listing_expiration_date": "20261231"}