celecoxib

Generic: celecoxib

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

Drug Facts

Product Profile

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

celecoxib 100 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4009
Product ID 70518-4009_3f901765-2f51-6c27-e063-6394a90a3ee8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208701
Listing Expiration 2026-12-31
Marketing Start 2024-02-05

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 705184009
Hyphenated Format 70518-4009

Supplemental Identifiers

RxCUI
205322
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 ANDA208701 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 POUCH in 1 BOX (70518-4009-0) / 1 CAPSULE in 1 POUCH (70518-4009-1)
source: ndc

Packages (1)

70518-4009-0 100 POUCH in 1 BOX (70518-4009-0) / 1 CAPSULE in 1 POUCH (70518-4009-1)

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": "3f901765-2f51-6c27-e063-6394a90a3ee8", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["JCX84Q7J1L"], "rxcui": ["205322"], "spl_set_id": ["56d64558-1fad-420e-8fcd-7103cd073127"], "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": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 POUCH in 1 BOX (70518-4009-0)  / 1 CAPSULE in 1 POUCH (70518-4009-1)", "package_ndc": "70518-4009-0", "marketing_start_date": "20240205"}], "brand_name": "Celecoxib", "product_id": "70518-4009_3f901765-2f51-6c27-e063-6394a90a3ee8", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "70518-4009", "generic_name": "Celecoxib", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Celecoxib", "active_ingredients": [{"name": "CELECOXIB", "strength": "100 mg/1"}], "application_number": "ANDA208701", "marketing_category": "ANDA", "marketing_start_date": "20240205", "listing_expiration_date": "20261231"}