concentrated ibuprofen infants

Generic: ibuprofen

Labeler: wal-mart stores, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name concentrated ibuprofen infants
Generic Name ibuprofen
Labeler wal-mart stores, inc.
Dosage Form SUSPENSION/ DROPS
Routes
ORAL
Active Ingredients

ibuprofen 50 mg/1.25mL

Manufacturer
Wal-Mart Stores, Inc.

Identifiers & Regulatory

Product NDC 49035-635
Product ID 49035-635_ad449225-ed60-4c66-9fd6-34bef9a4b42e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210755
Listing Expiration 2026-12-31
Marketing Start 2019-06-20

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 49035635
Hyphenated Format 49035-635

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 (49035-635-09) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

49035-635-09 1 BOTTLE in 1 CARTON (49035-635-09) / 30 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (50 mg/1.25mL)

Linked Drug Pages (1)

Concentrated ibuprofen infants ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ad449225-ed60-4c66-9fd6-34bef9a4b42e", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["204442"], "spl_set_id": ["00b7fc71-8cf0-4c12-a479-146408f7f91b"], "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": ["Wal-Mart Stores, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (49035-635-09)  / 30 mL in 1 BOTTLE", "package_ndc": "49035-635-09", "marketing_start_date": "20190620"}], "brand_name": "Concentrated ibuprofen infants", "product_id": "49035-635_ad449225-ed60-4c66-9fd6-34bef9a4b42e", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "49035-635", "generic_name": "Ibuprofen", "labeler_name": "Wal-Mart Stores, 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": "20190620", "listing_expiration_date": "20261231"}