celecoxib

Generic: celecoxib

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

celecoxib 200 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-669
Product ID 43063-669_3284fb4d-544b-d0dc-e063-6394a90a8af4
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 43063669
Hyphenated Format 43063-669

Supplemental Identifiers

RxCUI
205323
UNII
JCX84Q7J1L
NUI
N0000000160 M0001335 N0000175722

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
  • 200 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-10)
  • 14 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-14)
  • 20 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-20)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-30)
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-60)
source: ndc

Packages (5)

43063-669-10 10 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-10) 43063-669-14 14 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-14) 43063-669-20 20 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-20) 43063-669-30 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-30) 43063-669-60 60 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-60)

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": "3284fb4d-544b-d0dc-e063-6394a90a8af4", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["JCX84Q7J1L"], "rxcui": ["205323"], "spl_set_id": ["3191c9dc-bfdf-0591-e054-00144ff8d46c"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-10)", "package_ndc": "43063-669-10", "marketing_start_date": "20160428"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-14)", "package_ndc": "43063-669-14", "marketing_start_date": "20160428"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-20)", "package_ndc": "43063-669-20", "marketing_start_date": "20160428"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-30)", "package_ndc": "43063-669-30", "marketing_start_date": "20160428"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-60)", "package_ndc": "43063-669-60", "marketing_start_date": "20160428"}], "brand_name": "CELECOXIB", "product_id": "43063-669_3284fb4d-544b-d0dc-e063-6394a90a8af4", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "43063-669", "generic_name": "CELECOXIB", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CELECOXIB", "active_ingredients": [{"name": "CELECOXIB", "strength": "200 mg/1"}], "application_number": "ANDA207446", "marketing_category": "ANDA", "marketing_start_date": "20150923", "listing_expiration_date": "20261231"}