celecoxib

Generic: celecoxib

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name celecoxib
Generic Name celecoxib
Labeler torrent pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

celecoxib 400 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-310
Product ID 13668-310_bff3a32b-43e3-46cd-b5c3-b691617fe4fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207677
Listing Expiration 2026-12-31
Marketing Start 2015-12-23

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 13668310
Hyphenated Format 13668-310

Supplemental Identifiers

RxCUI
205322 205323 349514 686379
UPC
0313668441307 0313668307306 0313668310306
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 ANDA207677 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (13668-310-01)
  • 500 CAPSULE in 1 BOTTLE (13668-310-05)
  • 30 CAPSULE in 1 BOTTLE (13668-310-30)
  • 750 CAPSULE in 1 BOTTLE (13668-310-49)
  • 60 CAPSULE in 1 BOTTLE (13668-310-60)
  • 90 CAPSULE in 1 BOTTLE (13668-310-90)
source: ndc

Packages (6)

13668-310-01 100 CAPSULE in 1 BOTTLE (13668-310-01) 13668-310-05 500 CAPSULE in 1 BOTTLE (13668-310-05) 13668-310-30 30 CAPSULE in 1 BOTTLE (13668-310-30) 13668-310-49 750 CAPSULE in 1 BOTTLE (13668-310-49) 13668-310-60 60 CAPSULE in 1 BOTTLE (13668-310-60) 13668-310-90 90 CAPSULE in 1 BOTTLE (13668-310-90)

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": "bff3a32b-43e3-46cd-b5c3-b691617fe4fa", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0313668441307", "0313668307306", "0313668310306"], "unii": ["JCX84Q7J1L"], "rxcui": ["205322", "205323", "349514", "686379"], "spl_set_id": ["862698b6-2cc9-4374-992d-024beae6eba3"], "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": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (13668-310-01)", "package_ndc": "13668-310-01", "marketing_start_date": "20151223"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (13668-310-05)", "package_ndc": "13668-310-05", "marketing_start_date": "20151223"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (13668-310-30)", "package_ndc": "13668-310-30", "marketing_start_date": "20151223"}, {"sample": false, "description": "750 CAPSULE in 1 BOTTLE (13668-310-49)", "package_ndc": "13668-310-49", "marketing_start_date": "20151223"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (13668-310-60)", "package_ndc": "13668-310-60", "marketing_start_date": "20151223"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (13668-310-90)", "package_ndc": "13668-310-90", "marketing_start_date": "20151223"}], "brand_name": "celecoxib", "product_id": "13668-310_bff3a32b-43e3-46cd-b5c3-b691617fe4fa", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "13668-310", "generic_name": "celecoxib", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "celecoxib", "active_ingredients": [{"name": "CELECOXIB", "strength": "400 mg/1"}], "application_number": "ANDA207677", "marketing_category": "ANDA", "marketing_start_date": "20151223", "listing_expiration_date": "20261231"}