80948-002 NDC - PUROMA ()

Drug Information

  • Product NDC: 80948-002
  • Proprietary Name: PUROMA
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: ZENITH MICRO CONTROL
Product Type:
FDA Application Number: M003
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:12/20/2020

Package Information

No. Package Code Package Description Billing Unit
180948-002-0130 mL in 1 BOTTLE (80948-002-01)
280948-002-0260 mL in 1 BOTTLE (80948-002-02)
380948-002-0350 mL in 1 BOTTLE (80948-002-03)
480948-002-04100 mL in 1 BOTTLE (80948-002-04)
580948-002-05120 mL in 1 BOTTLE (80948-002-05)
680948-002-06320 mL in 1 BOTTLE (80948-002-06)
780948-002-07503 mL in 1 BOTTLE (80948-002-07)
880948-002-085000 mL in 1 CAN (80948-002-08)
980948-002-0950000 mL in 1 CAN (80948-002-09)
1080948-002-10200000 mL in 1 DRUM (80948-002-10)
1180948-002-1112 BOTTLE in 1 PACKAGE (80948-002-11) / 30 mL in 1 BOTTLE
1280948-002-126 BOTTLE in 1 PACKAGE (80948-002-12) / 60 mL in 1 BOTTLE
1380948-002-134 BOTTLE in 1 PACKAGE (80948-002-13) / 237 mL in 1 BOTTLE
1480948-002-14237 mL in 1 BOTTLE (80948-002-14)
1580948-002-15488 mL in 1 BOTTLE (80948-002-15)
1680948-002-162 BOTTLE in 1 PACKAGE (80948-002-16) / 488 mL in 1 BOTTLE
1780948-002-17947 mL in 1 BOTTLE (80948-002-17)

NDC Record

Field Name Field Value Definition
PRODUCT NDC80948-002The 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 NAMEPUROMAThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE12/20/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
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 NUMBERM003This 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 NAMEZENITH MICRO CONTROLName 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: 11/21/2025

Previous Code
Next Code