69994-002 NDC - BIOLLE GEL TEARS ()

Drug Information

  • Product NDC: 69994-002
  • Proprietary Name: Biolle Gel Tears
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: SAGE Ethnographic Research, dba Bioll�
Product Type:
FDA Application Number: part349
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:6/1/2015

Package Information

No. Package Code Package Description Billing Unit
169994-002-022 VIAL, SINGLE-USE in 1 CARTON (69994-002-02) / .6 mL in 1 VIAL, SINGLE-USE
269994-002-044 VIAL, SINGLE-USE in 1 CARTON (69994-002-04) / .6 mL in 1 VIAL, SINGLE-USE
369994-002-10102 VIAL, SINGLE-USE in 1 CARTON (69994-002-10) / .6 mL in 1 VIAL, SINGLE-USE
469994-002-3232 VIAL, SINGLE-USE in 1 CARTON (69994-002-32) / .6 mL in 1 VIAL, SINGLE-USEEA
569994-002-5252 VIAL, SINGLE-USE in 1 CARTON (69994-002-52) / .6 mL in 1 VIAL, SINGLE-USE
669994-002-7272 VIAL, SINGLE-USE in 1 CARTON (69994-002-72) / .6 mL in 1 VIAL, SINGLE-USE

NDC Record

Field Name Field Value Definition
PRODUCT NDC69994-002The 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 NAMEBiolle Gel TearsThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE6/1/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH FINALProduct 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 NUMBERpart349This 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 NAMESAGE Ethnographic Research, dba Bioll�Name 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: 12/19/2025

Previous Code
Next Code