elyxyb - celecoxib

Generic: celecoxib

Labeler: scilex pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name elyxyb - celecoxib
Generic Name celecoxib
Labeler scilex pharmaceuticals inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

celecoxib 120 mg/4.8mL

Manufacturer
SCILEX PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 69557-333
Product ID 69557-333_ad5c6af3-1790-4a13-b4e5-6e3af543b2a8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212157
Listing Expiration 2026-12-31
Marketing Start 2023-11-27

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 69557333
Hyphenated Format 69557-333

Supplemental Identifiers

RxCUI
2373454 2373460
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 elyxyb - celecoxib (source: ndc)
Generic Name celecoxib (source: ndc)
Application Number NDA212157 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/4.8mL
source: ndc
Packaging
  • 6 BOTTLE in 1 CARTON (69557-333-01) / 4.8 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69557-333-02) / 4.8 mL in 1 BOTTLE
source: ndc

Packages (2)

69557-333-01 6 BOTTLE in 1 CARTON (69557-333-01) / 4.8 mL in 1 BOTTLE 69557-333-02 1 BOTTLE in 1 CARTON (69557-333-02) / 4.8 mL in 1 BOTTLE

Ingredients (1)

celecoxib (120 mg/4.8mL)

Linked Drug Pages (1)

ELYXYB - celecoxib ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ad5c6af3-1790-4a13-b4e5-6e3af543b2a8", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["JCX84Q7J1L"], "rxcui": ["2373454", "2373460"], "spl_set_id": ["c8a5de07-9f27-4a54-a885-8089f0307bd7"], "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": ["SCILEX PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BOTTLE in 1 CARTON (69557-333-01)  / 4.8 mL in 1 BOTTLE", "package_ndc": "69557-333-01", "marketing_start_date": "20231127"}, {"sample": true, "description": "1 BOTTLE in 1 CARTON (69557-333-02)  / 4.8 mL in 1 BOTTLE", "package_ndc": "69557-333-02", "marketing_start_date": "20231127"}], "brand_name": "ELYXYB - celecoxib", "product_id": "69557-333_ad5c6af3-1790-4a13-b4e5-6e3af543b2a8", "dosage_form": "LIQUID", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69557-333", "generic_name": "celecoxib", "labeler_name": "SCILEX PHARMACEUTICALS INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ELYXYB - celecoxib", "active_ingredients": [{"name": "CELECOXIB", "strength": "120 mg/4.8mL"}], "application_number": "NDA212157", "marketing_category": "NDA", "marketing_start_date": "20231127", "listing_expiration_date": "20261231"}