NDC Package 70954-261-10 Dicyclomine Hydrochloride

Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

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:

70954-261-10

Package Description:

473 mL in 1 BOTTLE

Product Code:

70954-261

Proprietary Name:

Dicyclomine Hydrochloride

Non-Proprietary Name:

Dicyclomine Hydrochloride

Substance Name:

Dicyclomine Hydrochloride

Usage Information:

Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.

11-Digit NDC Billing Format:

70954026110

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

473 ML

NDC to RxNorm Crosswalk:

RxCUI: 991082 - dicyclomine HCl 10 MG in 5 mL Oral Solution

RxCUI: 991082 - dicyclomine hydrochloride 2 MG/ML Oral Solution

RxCUI: 991082 - dicyclomine HCl 10 MG per 5 ML Oral Solution

Product Type:

Human Prescription Drug

Labeler Name:

Novitium Pharma Llc

Dosage Form:

Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

DICYCLOMINE HYDROCHLORIDE 10 mg/5mL

Pharmacologic Class(es):

Anticholinergic - [EPC] (Established Pharmacologic Class)

Cholinergic Antagonists - [MoA] (Mechanism of Action)

Sample Package:

FDA Application Number:

ANDA214721

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

04-23-2021

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

70954 - Novitium Pharma Llc
- 70954-261 - Dicyclomine Hydrochloride
  - 70954-261-10 - 473 mL in 1 BOTTLE

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.

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 70954-261-10?

The NDC Packaged Code 70954-261-10 is assigned to a package of 473 ml in 1 bottle of Dicyclomine Hydrochloride, a human prescription drug labeled by Novitium Pharma Llc. The product's dosage form is solution and is administered via oral form.

Is NDC 70954-261 included in the NDC Directory?

Yes, Dicyclomine Hydrochloride with product code 70954-261 is active and included in the NDC Directory. The product was first marketed by Novitium Pharma Llc on April 23, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 70954-261-10?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 473.

What is the 11-digit format for NDC 70954-261-10?

The 11-digit format is 70954026110. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	70954-261-10	5-4-2	70954-0261-10

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