celecoxib

Generic: celecoxib

Labeler: asclemed usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name celecoxib
Generic Name celecoxib
Labeler asclemed usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

celecoxib 400 mg/1

Manufacturer
ASCLEMED USA INC.

Identifiers & Regulatory

Product NDC 76420-457
Product ID 76420-457_3c53a81b-bad9-2f96-e063-6394a90ae966
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204590
Listing Expiration 2026-12-31
Marketing Start 2016-03-16

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 76420457
Hyphenated Format 76420-457

Supplemental Identifiers

RxCUI
349514
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 ANDA204590 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (76420-457-00)
  • 1 CAPSULE in 1 BOTTLE (76420-457-01)
  • 7 CAPSULE in 1 BOTTLE (76420-457-07)
  • 10 CAPSULE in 1 BOTTLE (76420-457-10)
  • 14 CAPSULE in 1 BOTTLE (76420-457-14)
  • 20 CAPSULE in 1 BOTTLE (76420-457-20)
  • 30 CAPSULE in 1 BOTTLE (76420-457-30)
  • 60 CAPSULE in 1 BOTTLE (76420-457-60)
  • 90 CAPSULE in 1 BOTTLE (76420-457-90)
source: ndc

Packages (9)

76420-457-00 100 CAPSULE in 1 BOTTLE (76420-457-00) 76420-457-01 1 CAPSULE in 1 BOTTLE (76420-457-01) 76420-457-07 7 CAPSULE in 1 BOTTLE (76420-457-07) 76420-457-10 10 CAPSULE in 1 BOTTLE (76420-457-10) 76420-457-14 14 CAPSULE in 1 BOTTLE (76420-457-14) 76420-457-20 20 CAPSULE in 1 BOTTLE (76420-457-20) 76420-457-30 30 CAPSULE in 1 BOTTLE (76420-457-30) 76420-457-60 60 CAPSULE in 1 BOTTLE (76420-457-60) 76420-457-90 90 CAPSULE in 1 BOTTLE (76420-457-90)

Ingredients (1)

celecoxib (400 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": "3c53a81b-bad9-2f96-e063-6394a90ae966", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["JCX84Q7J1L"], "rxcui": ["349514"], "spl_set_id": ["0918fe50-bfb5-45d5-801c-968ba1bbbb9a"], "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": ["ASCLEMED USA INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (76420-457-00)", "package_ndc": "76420-457-00", "marketing_start_date": "20250813"}, {"sample": false, "description": "1 CAPSULE in 1 BOTTLE (76420-457-01)", "package_ndc": "76420-457-01", "marketing_start_date": "20250813"}, {"sample": false, "description": "7 CAPSULE in 1 BOTTLE (76420-457-07)", "package_ndc": "76420-457-07", "marketing_start_date": "20250813"}, {"sample": false, "description": "10 CAPSULE in 1 BOTTLE (76420-457-10)", "package_ndc": "76420-457-10", "marketing_start_date": "20250813"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (76420-457-14)", "package_ndc": "76420-457-14", "marketing_start_date": "20250813"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (76420-457-20)", "package_ndc": "76420-457-20", "marketing_start_date": "20250813"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (76420-457-30)", "package_ndc": "76420-457-30", "marketing_start_date": "20250813"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76420-457-60)", "package_ndc": "76420-457-60", "marketing_start_date": "20250813"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76420-457-90)", "package_ndc": "76420-457-90", "marketing_start_date": "20250813"}], "brand_name": "celecoxib", "product_id": "76420-457_3c53a81b-bad9-2f96-e063-6394a90ae966", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "76420-457", "generic_name": "celecoxib", "labeler_name": "ASCLEMED USA INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "celecoxib", "active_ingredients": [{"name": "CELECOXIB", "strength": "400 mg/1"}], "application_number": "ANDA204590", "marketing_category": "ANDA", "marketing_start_date": "20160316", "listing_expiration_date": "20261231"}