infants ibuprofen

Generic: infants ibuprofen

Labeler: family dollar services, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name infants ibuprofen
Generic Name infants ibuprofen
Labeler family dollar services, inc.
Dosage Form SUSPENSION/ DROPS
Routes
ORAL
Active Ingredients

ibuprofen 50 mg/1.25mL

Manufacturer
Family Dollar Services, Inc.

Identifiers & Regulatory

Product NDC 55319-637
Product ID 55319-637_e1e7c996-307e-41d3-a1f2-a1f2c6567f8d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210755
Listing Expiration 2026-12-31
Marketing Start 2024-03-27

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 55319637
Hyphenated Format 55319-637

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 infants ibuprofen (source: ndc)
Generic Name infants ibuprofen (source: ndc)
Application Number ANDA210755 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1.25mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (55319-637-09) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

55319-637-09 1 BOTTLE in 1 CARTON (55319-637-09) / 30 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (50 mg/1.25mL)

Linked Drug Pages (1)

Infants Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e1e7c996-307e-41d3-a1f2-a1f2c6567f8d", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["204442"], "spl_set_id": ["13143eb6-2fe8-487b-e063-6294a90a967e"], "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": ["Family Dollar Services, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (55319-637-09)  / 30 mL in 1 BOTTLE", "package_ndc": "55319-637-09", "marketing_start_date": "20240327"}], "brand_name": "Infants Ibuprofen", "product_id": "55319-637_e1e7c996-307e-41d3-a1f2-a1f2c6567f8d", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "55319-637", "generic_name": "Infants Ibuprofen", "labeler_name": "Family Dollar Services, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Infants Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "50 mg/1.25mL"}], "application_number": "ANDA210755", "marketing_category": "ANDA", "marketing_start_date": "20240327", "listing_expiration_date": "20261231"}