Robitussin 12 Hour Cough Relief Product NDC number 0031-8754 (dextromethorphan polistirex Drug)

Robitussin 12 Hour Cough Relief Product NDC number 0031-8754 (dextromethorphan polistirex Drug)
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What is Robitussin 12 Hour Cough Relief and Robitussin 12 Hour Cough Relief Product NDC number? Below is the most updated information on the Product NDC number 0031-8754 – Robitussin 12 Hour Cough Relief drug (dextromethorphan polistirex). Medical Code Data provides all information of this drug products including NDC product code, labeler name, dosage form & certification date.

What is Robitussin 12 Hour Cough Relief?

Robitussin 12 Hour Cough Relief is a HUMAN OTC DRUG labeled by Richmond Division of Wyeth. Robitussin 12 Hour Cough Relief, commonly known as dextromethorphan polistirex, is assigned Product NDC number 0031-8754. Robitussin 12 Hour Cough Relief is marketed under the ANDA category with application number ANDA091135. Robitussin 12 Hour Cough Relief‘s dosage form is SUSPENSION, EXTENDED RELEASE and is administered via ORAL form.

General Information

  • Proprietary Name / Trade Name: Robitussin 12 Hour Cough Relief
  • Non Proprietary Name / Generic Name: dextromethorphan polistirex
  • Product Type Name: HUMAN OTC DRUG
  • Proprietary Name Suffix: 

Uses & dosage information

  • Route Name: ORAL
  • Active strength Number: 30
  • Active Strength Unit: mg/5mL
  • Pharm Classes: 

We are updating more information on uses, dosage, side effects, warnings, reviews and pictures of Robitussin 12 Hour Cough Relief (generic name Robitussin 12 Hour Cough Relief) – Product NDC number 0031-8754 . Please visit frequently to get the most updated information

Distribution information

  • Marketing Category Name: ANDA
  • Labeler Name: Richmond Division of Wyeth
  • NDC Exclude Flag: N
  • FDA Public: Approved (Please Visit FDA for latest update)
  • Product ID: 0031-8754_adf0f894-ec19-49ea-8ee4-061e14ab22bd
  • Product NDC Number: 0031-8754
  • Application Number: ANDA091135
  • Start Marketing Date: 2016-07-05
  • End Marketing Date:–
  • Listing Record Certified Through: 2018-12-31

Above are up-to-date information of Robitussin 12 Hour Cough Relief – 0031-8754. There are no other drug products that have the same NDC identifier number. You can lookup more NDC number by clicking here

Useful information of the NDC Directory by FDA

What is NDC?

NDC (stands for National Drug Code) is a universal product identifier for human drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the United States. An NDC number for a specific drug is created by the the FDA and the manufacturer to ensure that products can be differentiated. The NDC database includes all information submitted to the FDA as part of drug listing requirements under section 510 of the FD&C Act, 21 USC 360.

How is the NDC formatted?

An NDC number contains 3 segments: the labeler code (identifies the manufacturer, repackager or distributor), the product code (identifies a specific strength, dosage form, and formulation) and the package code (identifies package types and sizes).

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Important notes regarding NDC

  • Assignment of an NDC number does not in any way denote FDA approval of the product.
  • Assignment of an NDC number does not denote that a product is covered or eligible for reimbursement by Medicare, Medicaid or other payers.
  • National Drug Code Directory does not include animal drugs, blood products, or human drugs that are not in final marketed form, such as Active Pharmaceutical Ingredients(APIs), drugs for further processing,…

Keywords: NCD Code lookup 2016, NDC Code lookup 2017 , NDC Code lookup 2018,  NDC number lookup 2019, NDC number lookup 2020 …

DISCLAIMER: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.


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