ibuprofen infants

Generic: ibuprofen

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

Drug Facts

Product Profile

Brand Name ibuprofen infants
Generic Name ibuprofen
Labeler hyvee inc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 50 mg/1.25mL

Manufacturer
HyVee Inc

Identifiers & Regulatory

Product NDC 42507-057
Product ID 42507-057_0ac8ac5d-d10b-40f6-94f0-e85c8a557e58
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075217
Listing Expiration 2027-12-31
Marketing Start 2000-09-03

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 42507057
Hyphenated Format 42507-057

Supplemental Identifiers

RxCUI
204442
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 ibuprofen infants (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA075217 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1.25mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (42507-057-05) / 15 mL in 1 BOTTLE (42507-057-00)
source: ndc

Packages (1)

42507-057-05 1 BOTTLE in 1 CARTON (42507-057-05) / 15 mL in 1 BOTTLE (42507-057-00)

Ingredients (1)

ibuprofen (50 mg/1.25mL)

Linked Drug Pages (1)

ibuprofen infants ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0ac8ac5d-d10b-40f6-94f0-e85c8a557e58", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["204442"], "spl_set_id": ["e8fcaf17-234a-4d64-b621-9ca505884b0a"], "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 (42507-057-05)  / 15 mL in 1 BOTTLE (42507-057-00)", "package_ndc": "42507-057-05", "marketing_start_date": "20000903"}], "brand_name": "ibuprofen infants", "product_id": "42507-057_0ac8ac5d-d10b-40f6-94f0-e85c8a557e58", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "42507-057", "generic_name": "ibuprofen", "labeler_name": "HyVee Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ibuprofen", "brand_name_suffix": "infants", "active_ingredients": [{"name": "IBUPROFEN", "strength": "50 mg/1.25mL"}], "application_number": "ANDA075217", "marketing_category": "ANDA", "marketing_start_date": "20000903", "listing_expiration_date": "20271231"}