ibuprofen pm

Generic: diphenhydramine citrate, ibuprofen

Labeler: hyvee inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen pm
Generic Name diphenhydramine citrate, ibuprofen
Labeler hyvee inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
HyVee Inc

Identifiers & Regulatory

Product NDC 42507-050
Product ID 42507-050_574cd550-b66e-4dad-abd8-3330fc429474
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079113
Listing Expiration 2027-12-31
Marketing Start 2009-03-02

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 42507050
Hyphenated Format 42507-050

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 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 (42507-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE (42507-050-80)
source: ndc

Packages (1)

42507-050-27 1 BOTTLE in 1 CARTON (42507-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE (42507-050-80)

Ingredients (2)

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

Linked Drug Pages (1)

ibuprofen pm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "574cd550-b66e-4dad-abd8-3330fc429474", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["4OD433S209", "WK2XYI10QM"], "rxcui": ["895664"], "spl_set_id": ["833a2bee-0e55-44f7-b80d-b336ebe52fc9"], "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": ["HyVee Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (42507-050-27)  / 80 TABLET, FILM COATED in 1 BOTTLE (42507-050-80)", "package_ndc": "42507-050-27", "marketing_start_date": "20090302"}], "brand_name": "ibuprofen pm", "product_id": "42507-050_574cd550-b66e-4dad-abd8-3330fc429474", "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": "42507-050", "generic_name": "diphenhydramine citrate, ibuprofen", "labeler_name": "HyVee Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "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": "20090302", "listing_expiration_date": "20271231"}