ibuprofen infants

Generic: ibuprofen

Labeler: -sun pharmaceutical industries, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen infants
Generic Name ibuprofen
Labeler -sun pharmaceutical industries, inc.
Dosage Form SUSPENSION/ DROPS
Routes
ORAL
Active Ingredients

ibuprofen 50 mg/1.25mL

Manufacturer
-Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-2146
Product ID 51672-2146_395bd971-1351-9371-e063-6294a90aa618
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA217261
Listing Expiration 2026-12-31
Marketing Start 2023-08-08

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 516722146
Hyphenated Format 51672-2146

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 ANDA217261 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1.25mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51672-2146-3) / 30 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51672-2146-5) / 15 mL in 1 BOTTLE
source: ndc

Packages (2)

51672-2146-3 1 BOTTLE in 1 CARTON (51672-2146-3) / 30 mL in 1 BOTTLE 51672-2146-5 1 BOTTLE in 1 CARTON (51672-2146-5) / 15 mL in 1 BOTTLE

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": "395bd971-1351-9371-e063-6294a90aa618", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["204442"], "spl_set_id": ["bc816597-a85a-4143-9f99-bb0699ca57c5"], "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": ["-Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-2146-3)  / 30 mL in 1 BOTTLE", "package_ndc": "51672-2146-3", "marketing_start_date": "20230808"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51672-2146-5)  / 15 mL in 1 BOTTLE", "package_ndc": "51672-2146-5", "marketing_start_date": "20241203"}], "brand_name": "IBUPROFEN Infants", "product_id": "51672-2146_395bd971-1351-9371-e063-6294a90aa618", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "51672-2146", "generic_name": "IBUPROFEN", "labeler_name": "-Sun Pharmaceutical Industries, 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": "ANDA217261", "marketing_category": "ANDA", "marketing_start_date": "20230808", "listing_expiration_date": "20261231"}