celecoxib

Generic: celecoxib

Labeler: mullan pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name celecoxib
Generic Name celecoxib
Labeler mullan pharmaceutical inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

celecoxib 200 mg/1

Manufacturer
Mullan Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 83301-0012
Product ID 83301-0012_3314bfff-6fee-b26b-e063-6294a90a5df2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210071
Listing Expiration 2026-12-31
Marketing Start 2024-01-01

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 833010012
Hyphenated Format 83301-0012

Supplemental Identifiers

RxCUI
205322 205323 686379
UPC
0383301001113
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 ANDA210071 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (83301-0012-1)
  • 500 CAPSULE in 1 BOTTLE (83301-0012-2)
  • 30 CAPSULE in 1 BOTTLE (83301-0012-3)
source: ndc

Packages (3)

83301-0012-1 100 CAPSULE in 1 BOTTLE (83301-0012-1) 83301-0012-2 500 CAPSULE in 1 BOTTLE (83301-0012-2) 83301-0012-3 30 CAPSULE in 1 BOTTLE (83301-0012-3)

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": "3314bfff-6fee-b26b-e063-6294a90a5df2", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0383301001113"], "unii": ["JCX84Q7J1L"], "rxcui": ["205322", "205323", "686379"], "spl_set_id": ["643e177f-216d-4dfa-824a-7516a488304e"], "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": ["Mullan Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (83301-0012-1)", "package_ndc": "83301-0012-1", "marketing_start_date": "20240101"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (83301-0012-2)", "package_ndc": "83301-0012-2", "marketing_start_date": "20240101"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (83301-0012-3)", "package_ndc": "83301-0012-3", "marketing_start_date": "20240101"}], "brand_name": "Celecoxib", "product_id": "83301-0012_3314bfff-6fee-b26b-e063-6294a90a5df2", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "83301-0012", "generic_name": "Celecoxib", "labeler_name": "Mullan Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Celecoxib", "active_ingredients": [{"name": "CELECOXIB", "strength": "200 mg/1"}], "application_number": "ANDA210071", "marketing_category": "ANDA", "marketing_start_date": "20240101", "listing_expiration_date": "20261231"}