celebrex

Generic: celecoxib

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name celebrex
Generic Name celecoxib
Labeler viatris specialty llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

celecoxib 100 mg/1

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 58151-083
Product ID 58151-083_0c321a7b-89e4-48cc-ab0b-1bd7620d7799
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020998
Listing Expiration 2026-12-31
Marketing Start 2024-09-13

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 58151083
Hyphenated Format 58151-083

Supplemental Identifiers

RxCUI
205322 205323 213468 213469 349514 352314 686379 686381
UPC
0358151085910 0358151084012 0358151082919 0358151083015
UNII
JCX84Q7J1L
NUI
N0000000160 M0001335 N0000175722

Packaging Origin

Original Packager
true

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 celebrex (source: ndc)
Generic Name celecoxib (source: ndc)
Application Number NDA020998 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (58151-083-01)
  • 500 CAPSULE in 1 BOTTLE (58151-083-05)
  • 100 BLISTER PACK in 1 CARTON (58151-083-88) / 1 CAPSULE in 1 BLISTER PACK (58151-083-32)
source: ndc

Packages (3)

58151-083-01 100 CAPSULE in 1 BOTTLE (58151-083-01) 58151-083-05 500 CAPSULE in 1 BOTTLE (58151-083-05) 58151-083-88 100 BLISTER PACK in 1 CARTON (58151-083-88) / 1 CAPSULE in 1 BLISTER PACK (58151-083-32)

Ingredients (1)

celecoxib (100 mg/1)

Linked Drug Pages (1)

CELEBREX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0c321a7b-89e4-48cc-ab0b-1bd7620d7799", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0358151085910", "0358151084012", "0358151082919", "0358151083015"], "unii": ["JCX84Q7J1L"], "rxcui": ["205322", "205323", "213468", "213469", "349514", "352314", "686379", "686381"], "spl_set_id": ["2d6675e4-5859-4be2-8037-a20ce9f707aa"], "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": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (58151-083-01)", "package_ndc": "58151-083-01", "marketing_start_date": "20240913"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (58151-083-05)", "package_ndc": "58151-083-05", "marketing_start_date": "20240913"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (58151-083-88)  / 1 CAPSULE in 1 BLISTER PACK (58151-083-32)", "package_ndc": "58151-083-88", "marketing_start_date": "20240917"}], "brand_name": "CELEBREX", "product_id": "58151-083_0c321a7b-89e4-48cc-ab0b-1bd7620d7799", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "58151-083", "generic_name": "Celecoxib", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CELEBREX", "active_ingredients": [{"name": "CELECOXIB", "strength": "100 mg/1"}], "application_number": "NDA020998", "marketing_category": "NDA", "marketing_start_date": "20240913", "listing_expiration_date": "20261231"}