21130-992 NDC - IBUPROFEN (IBUPROFEN TABLETS USP, 200MG)

Drug Information

Product NDC: 21130-992
Proprietary Name: Ibuprofen
Non Proprietary Name: Ibuprofen Tablets USP, 200mg
Active Ingredient(s): 200 mg/1 IBUPROFEN
Administration Route(s): ORAL
Dosage Form(s): TABLET
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:	BETTER LIVING BRANDS, LLC
Product Type:	HUMAN OTC DRUG
FDA Application Number:	ANDA091237
Marketing Category:	ANDA
Start Marketing Date:	8/8/2023

Package Information

No.	Package Code	Package Description	Billing Unit
1	21130-992-01	1 BOTTLE in 1 CARTON (21130-992-01) / 100 TABLET in 1 BOTTLE
2	21130-992-05	1 BOTTLE in 1 CARTON (21130-992-05) / 50 TABLET in 1 BOTTLE
3	21130-992-53	500 TABLET in 1 BOTTLE (21130-992-53)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	21130-992	This is the date that the labeler indicates was the start of its marketing of the drug product.
PRODUCT TYPE NAME	HUMAN OTC DRUG	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
PROPRIETARY NAME	Ibuprofen	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NON PROPRIETARY NAME	Ibuprofen Tablets USP, 200mg	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.
DOSAGE FORM NAME	TABLET	Name of Company corresponding to the labeler code segment of the Product NDC.
ROUTE NAME	ORAL	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
START MARKETING DATE	8/8/2023	The translation of the dosage form Code submitted by the firm.
MARKETING CATEGORY NAME	ANDA	The translation of the route code submitted by the firm, indicating route of administration.
APPLICATION NUMBER	ANDA091237	This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAME	BETTER LIVING BRANDS, LLC	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
SUBSTANCE NAME	IBUPROFEN	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.
ACTIVE NUMERATOR STRENGTH	200
ACTIVE INGRED UNIT	mg/1
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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