NDC Package 53225-3440-4 Readysharp-p80

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:
53225-3440-4
Package Description:
1 KIT in 1 CARTON * 2 mL in 1 AMPULE (0409-4713-42) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1560-18)
Product Code:
Proprietary Name:
Readysharp-p80
Usage Information:
Methylprednisolone acetate injectable suspension is contraindicated in patients with known hypersensitivity to the product and its constituents.Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.Methylprednisolone acetate injectable suspension is contraindicated for intrathecal administration. This formulation of methylprednisolone acetate has been associated with reports of severe medical events when administered by this route.Methylprednisolone acetate injectable suspension is contraindicated in systemic fungal infections, except when administered as an intra-articular injection for localized joint conditions (see WARNINGS, Infections, Fungal Infections). Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. MARCAINE is contraindicated in obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death.MARCAINE is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type or to other components of MARCAINE solutions.
11-Digit NDC Billing Format:
53225344004
Labeler Name:
Terrain Pharmaceuticals
Sample Package:
No
FDA Application Number:
NDA016964
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
12-29-2015
End Marketing Date:
10-26-2022
Listing Expiration Date:
10-26-2022
Exclude Flag:
D
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.

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
53225-3440-11 KIT in 1 KIT * 2 mL in 1 AMPULE (0409-4713-42) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1560-18)

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 53225-3440-4?

The NDC Packaged Code 53225-3440-4 is assigned to a package of 1 kit in 1 carton * 2 ml in 1 ampule (0409-4713-42) * 10 ml in 1 vial, single-dose (0409-1560-18) of Readysharp-p80, labeled by Terrain Pharmaceuticals. The product's dosage form is and is administered via form.

Is NDC 53225-3440 included in the NDC Directory?

No, Readysharp-p80 with product code 53225-3440 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Terrain Pharmaceuticals on December 29, 2015 and its listing in the NDC Directory is set to expire on October 26, 2022 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 53225-3440-4?

The 11-digit format is 53225344004. 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 5-4-1 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
5-4-153225-3440-45-4-253225-3440-04