0904-7915 NDC - IBUPROFEN ()

Drug Information

  • Product NDC: 0904-7915
  • Proprietary Name: Ibuprofen
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Major Pharmaceuticals
Product Type:
FDA Application Number: part343
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:5/24/1988
End Marketing Date:11/15/2021

Package Information

No. Package Code Package Description Billing Unit
10904-7915-801 BOTTLE, PLASTIC in 1 CARTON (0904-7915-80) / 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0904-7915The 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 NAMEIbuprofenThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/24/1988The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
END MARKETING DATE11/15/2021The translation of the dosage form Code submitted by the firm.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALThe translation of the route code submitted by the firm, indicating route of administration.
APPLICATION NUMBERpart343This 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 NAMEMajor PharmaceuticalsName of Company corresponding to the labeler code segment of the Product NDC.

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