direct safety ibuprofen (61245-085)

Drug Facts

Product Profile

Brand Name direct safety ibuprofen

Generic Name ibuprofen

Labeler conney safety products, llc

Dosage Form TABLET, COATED

Routes

ORAL

Active Ingredients

ibuprofen 200 mg/1

Manufacturer

Conney Safety Products, LLC

Identifiers & Regulatory

Product NDC 61245-085

Product ID 61245-085_3e5d63ea-c1b9-f7fc-e063-6394a90ae253

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA075010

Listing Expiration 2026-12-31

Marketing Start 2016-02-01

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 61245085

Hyphenated Format 61245-085

Supplemental Identifiers

RxCUI

310965

UNII

WK2XYI10QM

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 direct safety ibuprofen (source: ndc)

Generic Name ibuprofen (source: ndc)

Application Number ANDA075010 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/1

source: ndc

Packaging

250 PACKET in 1 BOX (61245-085-13) / 2 TABLET, COATED in 1 PACKET

source: ndc

Packages (1)

61245-085-13 250 PACKET in 1 BOX (61245-085-13) / 2 TABLET, COATED in 1 PACKET

Ingredients (1)

ibuprofen (200 mg/1)

Linked Drug Pages (1)

Direct Safety Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3e5d63ea-c1b9-f7fc-e063-6394a90ae253", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["310965"], "spl_set_id": ["28d45743-d298-29db-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": ["Conney Safety Products, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "250 PACKET in 1 BOX (61245-085-13)  / 2 TABLET, COATED in 1 PACKET", "package_ndc": "61245-085-13", "marketing_start_date": "20160201"}], "brand_name": "Direct Safety Ibuprofen", "product_id": "61245-085_3e5d63ea-c1b9-f7fc-e063-6394a90ae253", "dosage_form": "TABLET, COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "61245-085", "generic_name": "Ibuprofen", "labeler_name": "Conney Safety Products, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Direct Safety Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA075010", "marketing_category": "ANDA", "marketing_start_date": "20160201", "listing_expiration_date": "20261231"}