40032-358 NDC - HYDROCODONE BITARTRATE AND ACETAMINOPHEN ()

Drug Information

  • Product NDC: 40032-358
  • Proprietary Name: Hydrocodone Bitartrate and Acetaminophen
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Novel Laboratories, Inc.
Product Type:
FDA Application Number: ANDA206245
Marketing Category: ANDA
Start Marketing Date:12/1/2016

Package Information

No. Package Code Package Description Billing Unit
140032-358-01100 TABLET in 1 BOTTLE (40032-358-01)
240032-358-0330 TABLET in 1 BOTTLE (40032-358-03)
340032-358-05500 TABLET in 1 BOTTLE (40032-358-05)
440032-358-101000 TABLET in 1 BOTTLE (40032-358-10)

NDC Record

Field Name Field Value Definition
PRODUCT NDC40032-358The 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 AcetaminophenA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
START MARKETING DATE12/1/2016The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
MARKETING CATEGORY NAMEANDAThe translation of the route code submitted by the firm, indicating route of administration.
APPLICATION NUMBERANDA206245This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAMENovel Laboratories, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

Download Record

Download this NDC record record in Text format: Export

Download this NDC record record in Excel (CSV) format: Export

Download this NDC record record in XML format: Export

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