celecoxib

Generic: celecoxib

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name celecoxib
Generic Name celecoxib
Labeler quality care products, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

celecoxib 100 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-075
Product ID 83008-075_a556a447-0f7f-4c37-a3ec-87dfa75618b1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205129
Marketing Start 2024-07-24
Marketing End 2026-05-31

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 83008075
Hyphenated Format 83008-075

Supplemental Identifiers

RxCUI
205322
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 ANDA205129 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (83008-075-60)
source: ndc

Packages (1)

83008-075-60 60 CAPSULE in 1 BOTTLE (83008-075-60)

Ingredients (1)

celecoxib (100 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": "a556a447-0f7f-4c37-a3ec-87dfa75618b1", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["JCX84Q7J1L"], "rxcui": ["205322"], "spl_set_id": ["c4d35910-1f07-4eae-a1e6-75cc8c4f70c5"], "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": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (83008-075-60)", "package_ndc": "83008-075-60", "marketing_end_date": "20260531", "marketing_start_date": "20240724"}], "brand_name": "Celecoxib", "product_id": "83008-075_a556a447-0f7f-4c37-a3ec-87dfa75618b1", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "83008-075", "generic_name": "Celecoxib", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Celecoxib", "active_ingredients": [{"name": "CELECOXIB", "strength": "100 mg/1"}], "application_number": "ANDA205129", "marketing_category": "ANDA", "marketing_end_date": "20260531", "marketing_start_date": "20240724"}