celecoxib

Generic: celecoxib

Labeler: preferred pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name celecoxib
Generic Name celecoxib
Labeler preferred pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

celecoxib 200 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-8197
Product ID 68788-8197_6ff82426-c38c-411e-894d-548eae8e4b74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205129
Listing Expiration 2026-12-31
Marketing Start 2022-05-23

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 687888197
Hyphenated Format 68788-8197

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68788-8197-1)
  • 30 CAPSULE in 1 BOTTLE (68788-8197-3)
  • 60 CAPSULE in 1 BOTTLE (68788-8197-6)
  • 120 CAPSULE in 1 BOTTLE (68788-8197-8)
  • 90 CAPSULE in 1 BOTTLE (68788-8197-9)
source: ndc

Packages (5)

68788-8197-1 100 CAPSULE in 1 BOTTLE (68788-8197-1) 68788-8197-3 30 CAPSULE in 1 BOTTLE (68788-8197-3) 68788-8197-6 60 CAPSULE in 1 BOTTLE (68788-8197-6) 68788-8197-8 120 CAPSULE in 1 BOTTLE (68788-8197-8) 68788-8197-9 90 CAPSULE in 1 BOTTLE (68788-8197-9)

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": "6ff82426-c38c-411e-894d-548eae8e4b74", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["JCX84Q7J1L"], "rxcui": ["205323"], "spl_set_id": ["f2a5ffbd-49c4-4a97-867b-2b14a3675020"], "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": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68788-8197-1)", "package_ndc": "68788-8197-1", "marketing_start_date": "20220523"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68788-8197-3)", "package_ndc": "68788-8197-3", "marketing_start_date": "20220523"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (68788-8197-6)", "package_ndc": "68788-8197-6", "marketing_start_date": "20220523"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (68788-8197-8)", "package_ndc": "68788-8197-8", "marketing_start_date": "20220523"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68788-8197-9)", "package_ndc": "68788-8197-9", "marketing_start_date": "20220523"}], "brand_name": "Celecoxib", "product_id": "68788-8197_6ff82426-c38c-411e-894d-548eae8e4b74", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68788-8197", "generic_name": "Celecoxib", "labeler_name": "Preferred Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Celecoxib", "active_ingredients": [{"name": "CELECOXIB", "strength": "200 mg/1"}], "application_number": "ANDA205129", "marketing_category": "ANDA", "marketing_start_date": "20220523", "listing_expiration_date": "20261231"}