NDC 68210-1530 Dextromethorphan Hydrobromide

NDC Product Code 68210-1530

NDC CODE: 68210-1530

Proprietary Name: Dextromethorphan Hydrobromide What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Product Characteristics

Color(s):
RED (C48326)
Shape: OVAL (C48345)
Size(s):
15 MM
Score: 1

NDC Code Structure

NDC 68210-1530-1

Package Description: 1 BAG in 1 DRUM > 10000 CAPSULE, LIQUID FILLED in 1 BAG

NDC 68210-1530-4

Package Description: 1 BAG in 1 DRUM > 4000 CAPSULE, LIQUID FILLED in 1 BAG

NDC 68210-1530-6

Package Description: 1 BAG in 1 DRUM > 6000 CAPSULE, LIQUID FILLED in 1 BAG

NDC 68210-1530-8

Package Description: 1 BAG in 1 DRUM > 8000 CAPSULE, LIQUID FILLED in 1 BAG

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Dextromethorphan Hydrobromide with NDC 68210-1530 is a product labeled by Spirit Pharmaceuticals,llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1090487.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GELATIN (UNII: 2G86QN327L)
  • POVIDONE (UNII: FZ989GH94E)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Spirit Pharmaceuticals,llc
Labeler Code: 68210
Start Marketing Date: 07-15-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)

Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]

* Please review the disclaimer below.

Dextromethorphan Hydrobromide Product Label Images

Dextromethorphan Hydrobromide Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients (In Each Liquicap)

Dextromethorphan Hbr 15 mg

Purpose

Cough Suppressant

Uses Temporarily

Relieves cough due to minor throat and bronchial irritation may occur with a cold

Overdose Warning

In case of overdose,get medical help or contact a poison control center right away.

Direction

  • *do not take more than 8 liquidgels in any 24 hour period.*adults and children 12 years over : take 2 liquidgels every 6 to 8 hours, as needed*Children under 12years: ask a doctor

Other Information

  • *each tablet contains : Store at room temperature

Inactive Ingredients

FD &C Red No 40 IH, Polyethylene Glycol , Gelatin, Glycerin, Povidone, Purified water, Sorbitol

* Please review the disclaimer below.