concentrated ibuprofen infants

Generic: ibuprofen

Labeler: chain drug marketing association inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name concentrated ibuprofen infants
Generic Name ibuprofen
Labeler chain drug marketing association inc.
Dosage Form SUSPENSION/ DROPS
Routes
ORAL
Active Ingredients

ibuprofen 50 mg/1.25mL

Manufacturer
Chain Drug Marketing Association Inc.

Identifiers & Regulatory

Product NDC 83324-005
Product ID 83324-005_c9ae72d8-d205-4736-9bc4-2325cd77d36b
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210755
Listing Expiration 2026-12-31
Marketing Start 2023-11-03

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 83324005
Hyphenated Format 83324-005

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 concentrated ibuprofen infants (source: ndc)
Generic Name 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 (83324-005-30) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

Ingredients (1)

ibuprofen (50 mg/1.25mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "c9ae72d8-d205-4736-9bc4-2325cd77d36b", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["204442"], "spl_set_id": ["c9ae72d8-d205-4736-9bc4-2325cd77d36b"], "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": ["Chain Drug Marketing Association Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (83324-005-30)  / 30 mL in 1 BOTTLE", "package_ndc": "83324-005-30", "marketing_start_date": "20231103"}], "brand_name": "Concentrated ibuprofen infants", "product_id": "83324-005_c9ae72d8-d205-4736-9bc4-2325cd77d36b", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "83324-005", "generic_name": "Ibuprofen", "labeler_name": "Chain Drug Marketing Association Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Concentrated ibuprofen infants", "active_ingredients": [{"name": "IBUPROFEN", "strength": "50 mg/1.25mL"}], "application_number": "ANDA210755", "marketing_category": "ANDA", "marketing_start_date": "20231103", "listing_expiration_date": "20261231"}