Celecoxib

Generic: Celecoxib

Labeler: ASCLEMED USA INC.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name Celecoxib
Generic Name Celecoxib
Labeler ASCLEMED USA INC.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

CELECOXIB 200 mg/1

Identifiers & Regulatory

Product NDC 76420-392
Product ID 76420-392_381115fe-af65-afa5-e063-6294a90ab3e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205129
Listing Expiration 2026-12-31
Marketing Start 2020-12-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420392
Hyphenated Format 76420-392

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
  • 1000 CAPSULE in 1 BOTTLE (76420-392-00)
  • 1 CAPSULE in 1 BOTTLE (76420-392-01)
  • 500 CAPSULE in 1 BOTTLE (76420-392-05)
  • 7 CAPSULE in 1 BOTTLE (76420-392-07)
  • 100 CAPSULE in 1 BOTTLE (76420-392-10)
  • 14 CAPSULE in 1 BOTTLE (76420-392-14)
  • 20 CAPSULE in 1 BOTTLE (76420-392-20)
  • 30 CAPSULE in 1 BOTTLE (76420-392-30)
  • 60 CAPSULE in 1 BOTTLE (76420-392-60)
  • 90 CAPSULE in 1 BOTTLE (76420-392-90)
source: ndc

Packages (10)

Ingredients (1)

CELECOXIB (200 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "381115fe-af65-afa5-e063-6294a90ab3e7", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["JCX84Q7J1L"], "rxcui": ["205323"], "spl_set_id": ["cb4fc8ea-9476-4002-8cc0-4e05313eada3"], "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": "1000 CAPSULE in 1 BOTTLE (76420-392-00)", "package_ndc": "76420-392-00", "marketing_start_date": "20250620"}, {"sample": false, "description": "1 CAPSULE in 1 BOTTLE (76420-392-01)", "package_ndc": "76420-392-01", "marketing_start_date": "20250620"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (76420-392-05)", "package_ndc": "76420-392-05", "marketing_start_date": "20250620"}, {"sample": false, "description": "7 CAPSULE in 1 BOTTLE (76420-392-07)", "package_ndc": "76420-392-07", "marketing_start_date": "20250620"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (76420-392-10)", "package_ndc": "76420-392-10", "marketing_start_date": "20250620"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (76420-392-14)", "package_ndc": "76420-392-14", "marketing_start_date": "20250620"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (76420-392-20)", "package_ndc": "76420-392-20", "marketing_start_date": "20250620"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (76420-392-30)", "package_ndc": "76420-392-30", "marketing_start_date": "20250620"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76420-392-60)", "package_ndc": "76420-392-60", "marketing_start_date": "20250620"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76420-392-90)", "package_ndc": "76420-392-90", "marketing_start_date": "20250620"}], "brand_name": "Celecoxib", "product_id": "76420-392_381115fe-af65-afa5-e063-6294a90ab3e7", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "76420-392", "generic_name": "Celecoxib", "labeler_name": "ASCLEMED USA 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": "20201203", "listing_expiration_date": "20261231"}