profen ib

Generic: ibuprofen

Labeler: publix super markets inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name profen ib
Generic Name ibuprofen
Labeler publix super markets inc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
Publix Super Markets Inc

Identifiers & Regulatory

Product NDC 56062-166
Product ID 56062-166_5a15cea9-c0d8-4d59-9d6a-a8834a7cd876
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074937
Listing Expiration 2026-12-31
Marketing Start 2003-11-18

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 56062166
Hyphenated Format 56062-166

Supplemental Identifiers

RxCUI
197803
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 profen ib (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA074937 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (56062-166-26) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

56062-166-26 1 BOTTLE in 1 CARTON (56062-166-26) / 120 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

profen ib ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5a15cea9-c0d8-4d59-9d6a-a8834a7cd876", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["51fbfd25-3c4d-4de1-8fa2-e5b4b24022f2"], "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": ["Publix Super Markets Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (56062-166-26)  / 120 mL in 1 BOTTLE", "package_ndc": "56062-166-26", "marketing_start_date": "20031118"}], "brand_name": "profen ib", "product_id": "56062-166_5a15cea9-c0d8-4d59-9d6a-a8834a7cd876", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "56062-166", "generic_name": "Ibuprofen", "labeler_name": "Publix Super Markets Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "profen ib", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA074937", "marketing_category": "ANDA", "marketing_start_date": "20031118", "listing_expiration_date": "20261231"}