0603-3586 NDC - HYDROCODONE BITARTRATE AND IBUPROFEN ()

Drug Information

  • Product NDC: 0603-3586
  • Proprietary Name: Hydrocodone Bitartrate and Ibuprofen
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Par Health USA, LLC
Product Type:
FDA Application Number: ANDA077723
Marketing Category: ANDA
Start Marketing Date:11/6/2006
End Marketing Date:5/31/2022

Package Information

No. Package Code Package Description Billing Unit
10603-3586-21100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-3586-21)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0603-3586The 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.
PROPRIETARY NAMEHydrocodone Bitartrate and IbuprofenIndicates 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.
START MARKETING DATE11/6/2006The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
END MARKETING DATE5/31/2022The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the 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 NUMBERANDA077723This 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 NAMEPar Health USA, LLCThis is the date that the labeler indicates was the start of its marketing of the drug product.

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This page was last updated on: 1/2/2026

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