childrens ibuprofen oral suspension

Generic: ibuprofen

Labeler: pharmaceutical associates, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens ibuprofen oral suspension
Generic Name ibuprofen
Labeler pharmaceutical associates, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
Pharmaceutical Associates, Inc.

Identifiers & Regulatory

Product NDC 0121-0914
Product ID 0121-0914_e78c2544-9dfe-6399-e053-2995a90ac3d0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074916
Listing Expiration 2026-12-31
Marketing Start 1999-04-30

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 01210914
Hyphenated Format 0121-0914

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 childrens ibuprofen oral suspension (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA074916 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (0121-0914-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0914-05)
source: ndc

Packages (1)

0121-0914-00 10 TRAY in 1 CASE (0121-0914-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0914-05)

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Childrens Ibuprofen Oral Suspension ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e78c2544-9dfe-6399-e053-2995a90ac3d0", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["7a6832f2-2d80-483c-bde3-e6cacb7c318a"], "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": ["Pharmaceutical Associates, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0121-0914-00)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0914-05)", "package_ndc": "0121-0914-00", "marketing_start_date": "20200618"}], "brand_name": "Childrens Ibuprofen Oral Suspension", "product_id": "0121-0914_e78c2544-9dfe-6399-e053-2995a90ac3d0", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0121-0914", "generic_name": "Ibuprofen", "labeler_name": "Pharmaceutical Associates, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Ibuprofen Oral Suspension", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA074916", "marketing_category": "ANDA", "marketing_start_date": "19990430", "listing_expiration_date": "20261231"}