48083-330 NDC - CERTI-SINE ()

Drug Information

  • Product NDC: 48083-330
  • Proprietary Name: CERTI-SINE
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Certified Safety Manufacturing
Product Type:
FDA Application Number: M012
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:12/29/2017
End Marketing Date:10/31/2021

Package Information

No. Package Code Package Description Billing Unit
148083-330-2725 POUCH in 1 BOX (48083-330-27) / 2 TABLET in 1 POUCH
248083-330-3050 POUCH in 1 BOX (48083-330-30) / 2 TABLET in 1 POUCH
348083-330-3150 POUCH in 1 BOX (48083-330-31) / 2 TABLET in 1 POUCH
448083-330-33125 POUCH in 1 BOX (48083-330-33) / 2 TABLET in 1 POUCH
548083-330-36250 POUCH in 1 BOX (48083-330-36) / 2 TABLET in 1 POUCH
648083-330-39500 POUCH in 1 BOX (48083-330-39) / 2 TABLET in 1 POUCH
748083-330-411000 POUCH in 1 BOX (48083-330-41) / 2 TABLET in 1 POUCH

NDC Record

Field Name Field Value Definition
PRODUCT NDC48083-330The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMECERTI-SINEThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE12/29/2017This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE10/31/2021This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERM012This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMECertified Safety ManufacturingName of Company corresponding to the labeler code segment of the Product NDC.

Download Record

Download this NDC record record in Text format: Export

Download this NDC record record in Excel (CSV) format: Export

Download this NDC record record in XML format: Export

This page was last updated on: 7/4/2025

Previous Code
Next Code