celecoxib

Generic: celecoxib

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

celecoxib 100 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-168
Product ID 50268-168_48e822c3-2234-ef3e-e063-6394a90a45db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204519
Listing Expiration 2027-12-31
Marketing Start 2019-10-17

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 50268168
Hyphenated Format 50268-168

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 ANDA204519 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-168-15) / 1 CAPSULE in 1 BLISTER PACK (50268-168-11)
source: ndc

Packages (1)

50268-168-15 50 BLISTER PACK in 1 BOX (50268-168-15) / 1 CAPSULE in 1 BLISTER PACK (50268-168-11)

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": "48e822c3-2234-ef3e-e063-6394a90a45db", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["JCX84Q7J1L"], "rxcui": ["205322", "205323"], "spl_set_id": ["951df0f7-5fb7-40f5-e053-2995a90a1edd"], "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": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-168-15)  / 1 CAPSULE in 1 BLISTER PACK (50268-168-11)", "package_ndc": "50268-168-15", "marketing_start_date": "20191017"}], "brand_name": "Celecoxib", "product_id": "50268-168_48e822c3-2234-ef3e-e063-6394a90a45db", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50268-168", "generic_name": "Celecoxib", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Celecoxib", "active_ingredients": [{"name": "CELECOXIB", "strength": "100 mg/1"}], "application_number": "ANDA204519", "marketing_category": "ANDA", "marketing_start_date": "20191017", "listing_expiration_date": "20271231"}