celecoxib

Generic: celecoxib

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name celecoxib
Generic Name celecoxib
Labeler cipla usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

celecoxib 400 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-420
Product ID 69097-420_8df39b9c-af70-4ac3-ba9f-6e8e795ba961
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207446
Listing Expiration 2026-12-31
Marketing Start 2015-09-23

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 69097420
Hyphenated Format 69097-420

Supplemental Identifiers

RxCUI
205322 205323 349514 686379
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 ANDA207446 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (69097-420-02)
  • 60 CAPSULE in 1 BOTTLE (69097-420-03)
  • 480 CAPSULE in 1 BOTTLE (69097-420-11)
  • 10 BLISTER PACK in 1 CARTON (69097-420-21) / 10 CAPSULE in 1 BLISTER PACK (69097-420-19)
source: ndc

Packages (4)

69097-420-02 30 CAPSULE in 1 BOTTLE (69097-420-02) 69097-420-03 60 CAPSULE in 1 BOTTLE (69097-420-03) 69097-420-11 480 CAPSULE in 1 BOTTLE (69097-420-11) 69097-420-21 10 BLISTER PACK in 1 CARTON (69097-420-21) / 10 CAPSULE in 1 BLISTER PACK (69097-420-19)

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": "8df39b9c-af70-4ac3-ba9f-6e8e795ba961", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["JCX84Q7J1L"], "rxcui": ["205322", "205323", "349514", "686379"], "spl_set_id": ["d12625b1-2af9-4532-af91-d40b65eeffef"], "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": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (69097-420-02)", "package_ndc": "69097-420-02", "marketing_start_date": "20150923"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (69097-420-03)", "package_ndc": "69097-420-03", "marketing_start_date": "20150923"}, {"sample": false, "description": "480 CAPSULE in 1 BOTTLE (69097-420-11)", "package_ndc": "69097-420-11", "marketing_start_date": "20150923"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (69097-420-21)  / 10 CAPSULE in 1 BLISTER PACK (69097-420-19)", "package_ndc": "69097-420-21", "marketing_start_date": "20150923"}], "brand_name": "CELECOXIB", "product_id": "69097-420_8df39b9c-af70-4ac3-ba9f-6e8e795ba961", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69097-420", "generic_name": "CELECOXIB", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CELECOXIB", "active_ingredients": [{"name": "CELECOXIB", "strength": "400 mg/1"}], "application_number": "ANDA207446", "marketing_category": "ANDA", "marketing_start_date": "20150923", "listing_expiration_date": "20261231"}