ibuprofen

Generic: ibuprofen

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen
Generic Name ibuprofen
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ibuprofen 800 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8311
Product ID 0615-8311_f1acd267-02f3-49a1-b768-2f6f50d76bbd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078329
Listing Expiration 2026-12-31
Marketing Start 2018-08-24

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 06158311
Hyphenated Format 0615-8311

Supplemental Identifiers

RxCUI
197807
UNII
WK2XYI10QM
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 ibuprofen (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA078329 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8311-39)
source: ndc

Packages (1)

0615-8311-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8311-39)

Ingredients (1)

ibuprofen (800 mg/1)

Linked Drug Pages (1)

Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f1acd267-02f3-49a1-b768-2f6f50d76bbd", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197807"], "spl_set_id": ["f1842893-7a34-4f77-8231-55fb0c98b22b"], "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": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8311-39)", "package_ndc": "0615-8311-39", "marketing_start_date": "20190703"}], "brand_name": "Ibuprofen", "product_id": "0615-8311_f1acd267-02f3-49a1-b768-2f6f50d76bbd", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0615-8311", "generic_name": "Ibuprofen", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "800 mg/1"}], "application_number": "ANDA078329", "marketing_category": "ANDA", "marketing_start_date": "20180824", "listing_expiration_date": "20261231"}