celecoxib

Generic: celecoxib

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

Drug Facts

Product Profile

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

celecoxib 100 mg/1

Manufacturer
NIVAGEN PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 75834-237
Product ID 75834-237_482c41c4-9795-076e-e063-6394a90a3a85
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210628
Listing Expiration 2027-12-31
Marketing Start 2020-09-03

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 75834237
Hyphenated Format 75834-237

Supplemental Identifiers

RxCUI
205322 205323 349514 686379
UPC
0375834236605 0375834239606 0375834238012 0375834237015
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 ANDA210628 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (75834-237-01)
  • 500 CAPSULE in 1 BOTTLE (75834-237-05)
  • 100 CAPSULE in 1 BLISTER PACK (75834-237-11)
source: ndc

Packages (3)

75834-237-01 100 CAPSULE in 1 BOTTLE (75834-237-01) 75834-237-05 500 CAPSULE in 1 BOTTLE (75834-237-05) 75834-237-11 100 CAPSULE in 1 BLISTER PACK (75834-237-11)

Ingredients (1)

celecoxib (100 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": "482c41c4-9795-076e-e063-6394a90a3a85", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0375834236605", "0375834239606", "0375834238012", "0375834237015"], "unii": ["JCX84Q7J1L"], "rxcui": ["205322", "205323", "349514", "686379"], "spl_set_id": ["ae7943ab-b1fc-f08f-e053-2995a90a051e"], "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": ["NIVAGEN PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (75834-237-01)", "package_ndc": "75834-237-01", "marketing_start_date": "20200903"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (75834-237-05)", "package_ndc": "75834-237-05", "marketing_start_date": "20200903"}, {"sample": false, "description": "100 CAPSULE in 1 BLISTER PACK (75834-237-11)", "package_ndc": "75834-237-11", "marketing_start_date": "20200903"}], "brand_name": "CELECOXIB", "product_id": "75834-237_482c41c4-9795-076e-e063-6394a90a3a85", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "75834-237", "generic_name": "CELECOXIB", "labeler_name": "NIVAGEN PHARMACEUTICALS, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CELECOXIB", "active_ingredients": [{"name": "CELECOXIB", "strength": "100 mg/1"}], "application_number": "ANDA210628", "marketing_category": "ANDA", "marketing_start_date": "20200903", "listing_expiration_date": "20271231"}