childrens flanax oral

Generic: ibuprofen

Labeler: belmora llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens flanax oral
Generic Name ibuprofen
Labeler belmora llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
Belmora LLC

Identifiers & Regulatory

Product NDC 27854-777
Product ID 27854-777_1fb62f8c-355b-4760-90c8-a32f8b7dfde8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209179
Listing Expiration 2026-12-31
Marketing Start 2024-01-26

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 27854777
Hyphenated Format 27854-777

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 flanax oral (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA209179 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (27854-777-99) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

27854-777-99 1 BOTTLE in 1 CARTON (27854-777-99) / 120 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Childrens FLANAX ORAL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1fb62f8c-355b-4760-90c8-a32f8b7dfde8", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["9b9318cb-3bc7-40ca-bf8a-7495d93869b3"], "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": ["Belmora LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (27854-777-99)  / 120 mL in 1 BOTTLE", "package_ndc": "27854-777-99", "marketing_start_date": "20240126"}], "brand_name": "Childrens FLANAX ORAL", "product_id": "27854-777_1fb62f8c-355b-4760-90c8-a32f8b7dfde8", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "27854-777", "generic_name": "Ibuprofen", "labeler_name": "Belmora LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens FLANAX ORAL", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA209179", "marketing_category": "ANDA", "marketing_start_date": "20240126", "listing_expiration_date": "20261231"}