NDC Package 76420-891-30 Ibuprofen And Famotidine

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
76420-891-30
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Ibuprofen And Famotidine
Non-Proprietary Name:
Ibuprofen And Famotidine
Substance Name:
Famotidine; Ibuprofen
Usage Information:
Ibuprofen and famotidine tablet, a combination of the NSAID ibuprofen and the histamine H 2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies ( 14), Use in Specific Populations ( 8.5)] .
11-Digit NDC Billing Format:
76420089130
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Asclemed Usa, Inc.
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Sample Package:
No
FDA Application Number:
ANDA211890
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
08-04-2021
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
76420-891-01100 TABLET, FILM COATED in 1 BOTTLE
76420-891-05500 TABLET, FILM COATED in 1 BOTTLE
76420-891-066 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK
76420-891-6060 TABLET, FILM COATED in 1 BOTTLE
76420-891-9090 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 76420-891-30?

The NDC Packaged Code 76420-891-30 is assigned to a package of 30 tablet, film coated in 1 bottle of Ibuprofen And Famotidine, a human prescription drug labeled by Asclemed Usa, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 76420-891 included in the NDC Directory?

Yes, Ibuprofen And Famotidine with product code 76420-891 is active and included in the NDC Directory. The product was first marketed by Asclemed Usa, Inc. on August 04, 2021 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 76420-891-30?

The 11-digit format is 76420089130. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-276420-891-305-4-276420-0891-30