ibuprofen lysine

Generic: ibuprofen lysine

Labeler: xgen pharmaceuticals djb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen lysine
Generic Name ibuprofen lysine
Labeler xgen pharmaceuticals djb, inc.
Dosage Form SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ibuprofen lysine 10 mg/mL

Manufacturer
XGen Pharmaceuticals DJB, Inc.

Identifiers & Regulatory

Product NDC 39822-1030
Product ID 39822-1030_09c10e65-0cea-3052-e063-6394a90ae199
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202402
Listing Expiration 2026-12-31
Marketing Start 2016-04-08

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 398221030
Hyphenated Format 39822-1030

Supplemental Identifiers

RxCUI
1747294
UNII
N01ORX9D6S

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 ibuprofen lysine (source: ndc)
Generic Name ibuprofen lysine (source: ndc)
Application Number ANDA202402 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 3 VIAL in 1 CARTON (39822-1030-2) / 2 mL in 1 VIAL (39822-1030-1)
source: ndc

Packages (1)

39822-1030-2 3 VIAL in 1 CARTON (39822-1030-2) / 2 mL in 1 VIAL (39822-1030-1)

Ingredients (1)

ibuprofen lysine (10 mg/mL)

Linked Drug Pages (1)

Ibuprofen Lysine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "09c10e65-0cea-3052-e063-6394a90ae199", "openfda": {"unii": ["N01ORX9D6S"], "rxcui": ["1747294"], "spl_set_id": ["6cfdec66-9483-4abe-98d3-3a7d389cc952"], "manufacturer_name": ["XGen Pharmaceuticals DJB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 VIAL in 1 CARTON (39822-1030-2)  / 2 mL in 1 VIAL (39822-1030-1)", "package_ndc": "39822-1030-2", "marketing_start_date": "20160408"}], "brand_name": "Ibuprofen Lysine", "product_id": "39822-1030_09c10e65-0cea-3052-e063-6394a90ae199", "dosage_form": "SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "39822-1030", "generic_name": "Ibuprofen Lysine", "labeler_name": "XGen Pharmaceuticals DJB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen Lysine", "active_ingredients": [{"name": "IBUPROFEN LYSINE", "strength": "10 mg/mL"}], "application_number": "ANDA202402", "marketing_category": "ANDA", "marketing_start_date": "20160408", "listing_expiration_date": "20261231"}