leader ibuprofen pm (70000-0157)

Drug Facts

Product Profile

Brand Name leader ibuprofen pm

Generic Name diphenhydramine citrate, ibuprofen

Labeler cardinal health 110, llc. dba leader

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

diphenhydramine citrate 38 mg/1, ibuprofen 200 mg/1

Manufacturer

Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0157

Product ID 70000-0157_3987ffc4-5b9d-465e-a269-5dadb8ce95b2

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA079113

Listing Expiration 2026-12-31

Marketing Start 2016-11-23

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 700000157

Hyphenated Format 70000-0157

Supplemental Identifiers

RxCUI

895664

UNII

4OD433S209 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 leader ibuprofen pm (source: ndc)

Generic Name diphenhydramine citrate, ibuprofen (source: ndc)

Application Number ANDA079113 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

38 mg/1
200 mg/1

source: ndc

Packaging

1 BOTTLE in 1 CARTON (70000-0157-1) / 40 TABLET, FILM COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON (70000-0157-3) / 20 TABLET, FILM COATED in 1 BOTTLE

source: ndc

Packages (2)

70000-0157-1 1 BOTTLE in 1 CARTON (70000-0157-1) / 40 TABLET, FILM COATED in 1 BOTTLE 70000-0157-3 1 BOTTLE in 1 CARTON (70000-0157-3) / 20 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

diphenhydramine citrate (38 mg/1) ibuprofen (200 mg/1)

Linked Drug Pages (1)

Leader Ibuprofen PM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3987ffc4-5b9d-465e-a269-5dadb8ce95b2", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["4OD433S209", "WK2XYI10QM"], "rxcui": ["895664"], "spl_set_id": ["b19ad305-4464-4404-a011-584fa0c08521"], "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": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0157-1)  / 40 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "70000-0157-1", "marketing_start_date": "20161123"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0157-3)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "70000-0157-3", "marketing_start_date": "20241121"}], "brand_name": "Leader Ibuprofen PM", "product_id": "70000-0157_3987ffc4-5b9d-465e-a269-5dadb8ce95b2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "70000-0157", "generic_name": "diphenhydramine citrate, ibuprofen", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Leader Ibuprofen PM", "active_ingredients": [{"name": "DIPHENHYDRAMINE CITRATE", "strength": "38 mg/1"}, {"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA079113", "marketing_category": "ANDA", "marketing_start_date": "20161123", "listing_expiration_date": "20261231"}