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  5. NDC Package Code: 63561-0178-2 Astringent

NDC Package 63561-0178-2 Astringent

Calcium Acetate Monohydrate And Aluminum Sulfate Tetradecahydrate Powder, For Solution - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
63561-0178-2
Package Description:
12 PACKET in 1 CARTON / 2299 mg in 1 PACKET (63561-0178-1)
Product Code:
63561-0178
Proprietary Name:
Astringent
Non-Proprietary Name:
Calcium Acetate Monohydrate And Aluminum Sulfate Tetradecahydrate
Substance Name:
Aluminum Sulfate Tetradecahydrate; Calcium Acetate Monohydrate
Usage Information:
Dissolve 1 to 3 packets in a pint (16 oz) of cool or warm waterstir until fully dissolved; do not strain or filter. The resulting mixture contains 0.16% (1 packet), 0.32% (2 packets), or 0.48% (3 packets) aluminum acetate and is ready for use.For use as a soak:soak affected area for 15 to 30 minutes as needed, or as directed by a doctorrepeat 3 times a day or as directed by a doctordiscard solution after each useFor use as a compress or wet dressing:soak a clean, soft cloth in the solutionapply cloth loosely to affected area for 15 to 30 minutesrepeat as needed or as directed by a doctordiscard solution after each use
11-Digit NDC Billing Format:
63561017802
NDC to RxNorm Crosswalk:
  • RxCUI: 1250234 - aluminum sulfate 1347 MG / calcium acetate 952 MG per 160 ML Topical Solution
  • RxCUI: 1250234 - aluminum sulfate 8.42 MG/ML / calcium acetate 5.95 MG/ML Topical Solution
  • RxCUI: 1250234 - (3 Packets (aluminum sulfate 1347 MG Powder / calcium acetate 952 MG Powder)) per 16 OZ Topical Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Granulation Technology, Inc.
    Dosage Form:
    Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
    Administration Route(s):
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Active Ingredient(s):
  • ALUMINUM SULFATE TETRADECAHYDRATE 1347 mg/2299mg
  • CALCIUM ACETATE MONOHYDRATE 952 mg/2299mg
    • Pharmacologic Class(es):
  • Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Calcium - [CS]
  • Cations, Divalent - [CS]
  • Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Phosphate Binder - [EPC] (Established Pharmacologic Class)
  • Phosphate Chelating Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    part347
    Marketing Category:
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date:
    10-05-2023
    Listing Expiration Date:
    12-31-2024
    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.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63561-0178-2?

    The NDC Packaged Code 63561-0178-2 is assigned to a package of 12 packet in 1 carton / 2299 mg in 1 packet (63561-0178-1) of Astringent, a human over the counter drug labeled by Granulation Technology, Inc.. The product's dosage form is powder, for solution and is administered via topical form.

    Is NDC 63561-0178 included in the NDC Directory?

    Yes, Astringent with product code 63561-0178 is active and included in the NDC Directory. The product was first marketed by Granulation Technology, Inc. on October 05, 2023 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 11-digit format for NDC 63561-0178-2?

    The 11-digit format is 63561017802. 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
    5-4-163561-0178-25-4-263561-0178-02