celecoxib

Generic: celecoxib

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name celecoxib
Generic Name celecoxib
Labeler micro labs limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

celecoxib 400 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-145
Product ID 42571-145_350160e1-34ab-f7e3-e063-6394a90a4508
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204776
Listing Expiration 2026-12-31
Marketing Start 2018-06-01

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 42571145
Hyphenated Format 42571-145

Supplemental Identifiers

RxCUI
205322 205323 349514 686379
UPC
0342571144302 0342571142308 0342571143305
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 ANDA204776 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (42571-145-05)
  • 60 CAPSULE in 1 BOTTLE (42571-145-60)
source: ndc

Packages (2)

42571-145-05 500 CAPSULE in 1 BOTTLE (42571-145-05) 42571-145-60 60 CAPSULE in 1 BOTTLE (42571-145-60)

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": "350160e1-34ab-f7e3-e063-6394a90a4508", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0342571144302", "0342571142308", "0342571143305"], "unii": ["JCX84Q7J1L"], "rxcui": ["205322", "205323", "349514", "686379"], "spl_set_id": ["408b30d6-f5c2-4239-b993-d8f77a8e160b"], "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": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (42571-145-05)", "package_ndc": "42571-145-05", "marketing_start_date": "20180601"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (42571-145-60)", "package_ndc": "42571-145-60", "marketing_start_date": "20180601"}], "brand_name": "CELECOXIB", "product_id": "42571-145_350160e1-34ab-f7e3-e063-6394a90a4508", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "42571-145", "generic_name": "Celecoxib", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CELECOXIB", "active_ingredients": [{"name": "CELECOXIB", "strength": "400 mg/1"}], "application_number": "ANDA204776", "marketing_category": "ANDA", "marketing_start_date": "20180601", "listing_expiration_date": "20261231"}