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58602-893 NDC - ACETAMINOPHEN AND IBUPROFEN

Drug Information

Product NDC: 58602-893

Proprietary Name: Acetaminophen and Ibuprofen

Non Proprietary Name: Acetaminophen and Ibuprofen

Active Ingredient(s):
  • 250 mg/1 ACETAMINOPHEN;
  • 125 mg/1 IBUPROFEN


Administration Route(s): ORAL

Dosage Form(s): TABLET, FILM COATED

Pharmacy Class(es):
  • Anti-Inflammatory Agents;
  • Non-Steroidal [CS];
  • Cyclooxygenase Inhibitors [MoA];
  • Nonsteroidal Anti-inflammatory Drug [EPC]

Labeler Information

Labeler Name: Aurohealth LLC
Product Type: HUMAN OTC DRUG
FDA Application Number: ANDA218359
Marketing Category: ANDA
Start Marketing Date:3/26/2024

Package Information

No. Package Code Package Description Billing Unit
158602-893-011 BOTTLE, PLASTIC in 1 CARTON (58602-893-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
258602-893-031 BOTTLE in 1 CARTON (58602-893-03) / 10 TABLET, FILM COATED in 1 BOTTLE
358602-893-071 BOTTLE in 1 CARTON (58602-893-07) / 24 TABLET, FILM COATED in 1 BOTTLE
458602-893-111 BOTTLE in 1 CARTON (58602-893-11) / 36 TABLET, FILM COATED in 1 BOTTLE
558602-893-141 BOTTLE in 1 CARTON (58602-893-14) / 50 TABLET, FILM COATED in 1 BOTTLE
658602-893-211 BOTTLE in 1 CARTON (58602-893-21) / 100 TABLET, FILM COATED in 1 BOTTLE
758602-893-291 BOTTLE in 1 CARTON (58602-893-29) / 150 TABLET, FILM COATED in 1 BOTTLE
858602-893-35225 TABLET, FILM COATED in 1 BOTTLE (58602-893-35)
958602-893-40500 TABLET, FILM COATED in 1 BOTTLE (58602-893-40)
1058602-893-411000 TABLET, FILM COATED in 1 BOTTLE (58602-893-41)
1158602-893-44400 TABLET, FILM COATED in 1 BOTTLE (58602-893-44)
1258602-893-461 BOTTLE, PLASTIC in 1 CARTON (58602-893-46) / 18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
1358602-893-491 BOTTLE, PLASTIC in 1 CARTON (58602-893-49) / 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
1458602-893-51216 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-51)
1558602-893-611 BLISTER PACK in 1 CARTON (58602-893-61) / 2 TABLET, FILM COATED in 1 BLISTER PACK
1658602-893-62216 TABLET, FILM COATED in 1 BOTTLE (58602-893-62)
1758602-893-651 BOTTLE in 1 CARTON (58602-893-65) / 72 TABLET, FILM COATED in 1 BOTTLE
1858602-893-731 BOTTLE in 1 CARTON (58602-893-73) / 20 TABLET, FILM COATED in 1 BOTTLE
1958602-893-781 BOTTLE, PLASTIC in 1 CARTON (58602-893-78) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2058602-893-79500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-79)
2158602-893-801 BOTTLE, PLASTIC in 1 CARTON (58602-893-80) / 72 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2258602-893-821 BOTTLE in 1 CARTON (58602-893-82) / 18 TABLET, FILM COATED in 1 BOTTLE
2358602-893-84225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-84)
2458602-893-851 BOTTLE, PLASTIC in 1 CARTON (58602-893-85) / 36 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2558602-893-88750 TABLET, FILM COATED in 1 BOTTLE (58602-893-88)
2658602-893-941 BOTTLE, PLASTIC in 1 CARTON (58602-893-94) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2758602-893-95750 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-95)
2858602-893-961 BOTTLE, PLASTIC in 1 CARTON (58602-893-96) / 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2958602-893-99400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-99)

NDC Record

Field Name Field Value Definition
PRODUCT NDC58602-893The 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 NAMEHUMAN OTC DRUGIndicates 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 NAMEAcetaminophen and IbuprofenThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAcetaminophen and IbuprofenThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/26/2024This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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.
APPLICATION NUMBERANDA218359This 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 NAMEAurohealth LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACETAMINOPHEN; IBUPROFENAn 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 STRENGTH250; 125 
ACTIVE INGRED UNITmg/1; mg/1 
PHARM CLASSESAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] 

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This page was last updated on: 4/12/2024
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