childrens ibuprofen

Generic: ibuprofen

Labeler: precision dose inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens ibuprofen
Generic Name ibuprofen
Labeler precision dose inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
Precision Dose Inc.

Identifiers & Regulatory

Product NDC 68094-503
Product ID 68094-503_569c23f2-55ee-4921-80ca-9362c8ce58b6
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074937
Listing Expiration 2026-12-31
Marketing Start 2006-09-14

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 68094503
Hyphenated Format 68094-503

Supplemental Identifiers

RxCUI
197803
UNII
WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

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 childrens ibuprofen (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
  • 10 TRAY in 1 CASE (68094-503-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-503-59)
  • 3 TRAY in 1 CASE (68094-503-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-503-59)
source: ndc

Packages (2)

68094-503-61 10 TRAY in 1 CASE (68094-503-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-503-59) 68094-503-62 3 TRAY in 1 CASE (68094-503-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-503-59)

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Childrens Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "569c23f2-55ee-4921-80ca-9362c8ce58b6", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["59b881f9-1830-4bce-99d2-9770c9b2575f"], "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": ["Precision Dose Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (68094-503-61)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-503-59)", "package_ndc": "68094-503-61", "marketing_start_date": "20060914"}, {"sample": false, "description": "3 TRAY in 1 CASE (68094-503-62)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-503-59)", "package_ndc": "68094-503-62", "marketing_start_date": "20060914"}], "brand_name": "Childrens Ibuprofen", "product_id": "68094-503_569c23f2-55ee-4921-80ca-9362c8ce58b6", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68094-503", "generic_name": "Ibuprofen", "labeler_name": "Precision Dose Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA074937", "marketing_category": "ANDA", "marketing_start_date": "20060914", "listing_expiration_date": "20261231"}