ibuprofen pm

Generic: ibuprofen, diphenhydramine hcl

Labeler: premier value alliance llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen pm
Generic Name ibuprofen, diphenhydramine hcl
Labeler premier value alliance llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1, ibuprofen 200 mg/1

Manufacturer
Premier Value Alliance LLC

Identifiers & Regulatory

Product NDC 68016-057
Product ID 68016-057_21afce91-afbe-4b38-a8a5-8775148835e8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090397
Listing Expiration 2026-12-31
Marketing Start 2018-10-25

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 68016057
Hyphenated Format 68016-057

Supplemental Identifiers

RxCUI
901814
UNII
TC2D6JAD40 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 ibuprofen, diphenhydramine hcl (source: ndc)
Application Number ANDA090397 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68016-057-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
source: ndc

Packages (1)

68016-057-40 1 BOTTLE in 1 CARTON (68016-057-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE

Ingredients (2)

diphenhydramine hydrochloride (25 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": "21afce91-afbe-4b38-a8a5-8775148835e8", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["TC2D6JAD40", "WK2XYI10QM"], "rxcui": ["901814"], "spl_set_id": ["21afce91-afbe-4b38-a8a5-8775148835e8"], "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": ["Premier Value Alliance LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68016-057-40)  / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "68016-057-40", "marketing_start_date": "20181025"}], "brand_name": "Ibuprofen PM", "product_id": "68016-057_21afce91-afbe-4b38-a8a5-8775148835e8", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "68016-057", "generic_name": "IBUPROFEN, DIPHENHYDRAMINE HCL", "labeler_name": "Premier Value Alliance LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen PM", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA090397", "marketing_category": "ANDA", "marketing_start_date": "20181025", "listing_expiration_date": "20261231"}