17856-0043 NDC - HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ()

Drug Information

  • Product NDC: 17856-0043
  • Proprietary Name: Hydrocodone Bitartrate and Homatropine Methylbromide
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Atlantic Biologicals Corps
Product Type:
FDA Application Number: ANDA040613
Marketing Category: ANDA
Start Marketing Date:2/8/2008

Package Information

No. Package Code Package Description Billing Unit
117856-0043-15 mL in 1 CUP, UNIT-DOSE (17856-0043-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC17856-0043The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAMEHydrocodone Bitartrate and Homatropine MethylbromideThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE2/8/2008This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAThe translation of the route code submitted by the firm, indicating route of administration.
APPLICATION NUMBERANDA040613This 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 NAMEAtlantic Biologicals CorpsName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 1/16/2026