celecoxib

Generic: celecoxib

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

Drug Facts

Product Profile

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

celecoxib 400 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-159
Product ID 50228-159_2fb1966b-b01a-752b-e063-6294a90ac79d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205129
Listing Expiration 2026-12-31
Marketing Start 2020-12-03

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 50228159
Hyphenated Format 50228-159

Supplemental Identifiers

RxCUI
205322 205323 349514 686379
UPC
0350228159302 0350228157056 0350228158305 0350228158015 0350228158107 0350228159609 0350228157018 0350228157100 0350228157308 0350228156103 0350228156608 0350228156301 0350228158053 0350228159050
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 ANDA205129 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (50228-159-05)
  • 30 CAPSULE in 1 BOTTLE (50228-159-30)
  • 60 CAPSULE in 1 BOTTLE (50228-159-60)
source: ndc

Packages (3)

50228-159-05 500 CAPSULE in 1 BOTTLE (50228-159-05) 50228-159-30 30 CAPSULE in 1 BOTTLE (50228-159-30) 50228-159-60 60 CAPSULE in 1 BOTTLE (50228-159-60)

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": "2fb1966b-b01a-752b-e063-6294a90ac79d", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0350228159302", "0350228157056", "0350228158305", "0350228158015", "0350228158107", "0350228159609", "0350228157018", "0350228157100", "0350228157308", "0350228156103", "0350228156608", "0350228156301", "0350228158053", "0350228159050"], "unii": ["JCX84Q7J1L"], "rxcui": ["205322", "205323", "349514", "686379"], "spl_set_id": ["8709cbe7-3de1-4908-a0a9-53002bcee15b"], "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": ["ScieGen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (50228-159-05)", "package_ndc": "50228-159-05", "marketing_start_date": "20201203"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (50228-159-30)", "package_ndc": "50228-159-30", "marketing_start_date": "20201203"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (50228-159-60)", "package_ndc": "50228-159-60", "marketing_start_date": "20201203"}], "brand_name": "Celecoxib", "product_id": "50228-159_2fb1966b-b01a-752b-e063-6294a90ac79d", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50228-159", "generic_name": "Celecoxib", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Celecoxib", "active_ingredients": [{"name": "CELECOXIB", "strength": "400 mg/1"}], "application_number": "ANDA205129", "marketing_category": "ANDA", "marketing_start_date": "20201203", "listing_expiration_date": "20261231"}