celecoxib

Generic: celecoxib

Labeler: tianjin tianyao pharmaceuticals co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name celecoxib
Generic Name celecoxib
Labeler tianjin tianyao pharmaceuticals co., ltd.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

celecoxib 200 mg/1

Manufacturer
Tianjin Tianyao Pharmaceuticals Co., Ltd.

Identifiers & Regulatory

Product NDC 57582-213
Product ID 57582-213_30949e07-504d-43c2-b0d1-1c26dcaed176
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207872
Listing Expiration 2026-12-31
Marketing Start 2020-02-25

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 57582213
Hyphenated Format 57582-213

Supplemental Identifiers

RxCUI
205322 205323 349514 686379
UPC
0357582214029 0357582213015 0357582213039 0357582212018 0357582211011 0357582214012 0357582213022 0357582212032 0357582212025
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 celecoxib (source: ndc)
Generic Name celecoxib (source: ndc)
Application Number ANDA207872 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (57582-213-01)
  • 500 CAPSULE in 1 BOTTLE (57582-213-02)
  • 100 CAPSULE in 1 CARTON (57582-213-03)
source: ndc

Packages (3)

57582-213-01 100 CAPSULE in 1 BOTTLE (57582-213-01) 57582-213-02 500 CAPSULE in 1 BOTTLE (57582-213-02) 57582-213-03 100 CAPSULE in 1 CARTON (57582-213-03)

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": "30949e07-504d-43c2-b0d1-1c26dcaed176", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0357582214029", "0357582213015", "0357582213039", "0357582212018", "0357582211011", "0357582214012", "0357582213022", "0357582212032", "0357582212025"], "unii": ["JCX84Q7J1L"], "rxcui": ["205322", "205323", "349514", "686379"], "spl_set_id": ["76f9bcb7-0e94-485f-816d-61d4e1ed24e0"], "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": ["Tianjin Tianyao Pharmaceuticals Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (57582-213-01)", "package_ndc": "57582-213-01", "marketing_start_date": "20200225"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (57582-213-02)", "package_ndc": "57582-213-02", "marketing_start_date": "20200225"}, {"sample": false, "description": "100 CAPSULE in 1 CARTON (57582-213-03)", "package_ndc": "57582-213-03", "marketing_start_date": "20200225"}], "brand_name": "Celecoxib", "product_id": "57582-213_30949e07-504d-43c2-b0d1-1c26dcaed176", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "57582-213", "generic_name": "Celecoxib", "labeler_name": "Tianjin Tianyao Pharmaceuticals Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Celecoxib", "active_ingredients": [{"name": "CELECOXIB", "strength": "200 mg/1"}], "application_number": "ANDA207872", "marketing_category": "ANDA", "marketing_start_date": "20200225", "listing_expiration_date": "20261231"}