49035-635 NDC - CONCENTRATED IBUPROFEN INFANTS (IBUPROFEN)

Drug Information

Product NDC: 49035-635
Proprietary Name: Concentrated ibuprofen infants
Non Proprietary Name: Ibuprofen
Active Ingredient(s): 50 mg/1.25mL IBUPROFEN
Administration Route(s): ORAL
Dosage Form(s): SUSPENSION/ DROPS
Pharmacy Class(es): Anti-Inflammatory Agents; Non-Steroidal [CS]; Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	Wal-Mart Stores, Inc.
Product Type:	HUMAN OTC DRUG
FDA Application Number:	ANDA210755
Marketing Category:	ANDA
Start Marketing Date:	6/20/2019

Package Information

No.	Package Code	Package Description	Billing Unit
1	49035-635-09	1 BOTTLE in 1 CARTON (49035-635-09) / 30 mL in 1 BOTTLE

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	49035-635	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN OTC DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	Concentrated ibuprofen infants	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Ibuprofen	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	SUSPENSION/ DROPS	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	6/20/2019	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	ANDA	This is the date that the labeler indicates was the start of its marketing of the drug product.
APPLICATION NUMBER	ANDA210755	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAME	Wal-Mart Stores, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	IBUPROFEN	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	50
ACTIVE INGRED UNIT	mg/1.25mL
PHARM CLASSES	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]

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This page was last updated on: 12/6/2025

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