1. Home
  2. Labeler Index
  3. Cipla Usa Inc.
  4. NDC Product Code: 69097-535 Phenylephrine Hydrochloride

NDC 69097-535 Phenylephrine Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 69097-535?
  4. Phenylephrine Hydrochloride Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
69097-535
Proprietary Name:
Phenylephrine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Cipla Usa Inc.
Labeler Code:
69097
Product Label ID:
4a403897-c688-469a-ba71-b5558eeffb26
Start Marketing Date: [9]
06-01-2018
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 69097-535-96

Package Description: 10 CARTON in 1 CELLO PACK / 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (69097-535-35) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE

Product Details

What is NDC 69097-535?

The NDC code 69097-535 is assigned by the FDA to the product Phenylephrine Hydrochloride which is product labeled by Cipla Usa Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 69097-535-96 10 carton in 1 cello pack / 1 vial, pharmacy bulk package in 1 carton (69097-535-35) / 5 ml in 1 vial, pharmacy bulk package. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Phenylephrine Hydrochloride?

The Pharmacy Bulk Vial is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion. Each closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. The Pharmacy Bulk Vial is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Dispensing from a pharmacy bulk vial should be completed within 4 hours after the vial is penetrated.

Which are Phenylephrine Hydrochloride UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Phenylephrine Hydrochloride Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Phenylephrine Hydrochloride?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1232651 - phenylephrine HCl 10 MG/ML Injectable Solution
  • RxCUI: 1232651 - phenylephrine hydrochloride 10 MG/ML Injectable Solution
  • RxCUI: 1232651 - phenylephrine hydrochloride 1 % Injectable Solution
  • RxCUI: 1232651 - phenylephrine hydrochloride 100 MG per 10 ML Injectable Solution
  • RxCUI: 1232651 - phenylephrine hydrochloride 50 MG per 5 ML Injectable Solution

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".