0990-7984 NDC - SODIUM CHLORIDE ()

Drug Information

Product NDC: 0990-7984
Proprietary Name: Sodium Chloride
Non Proprietary Name:
Active Ingredient(s): 900 mg/100mL SODIUM CHLORIDE
Administration Route(s):
Dosage Form(s):
Pharmacy Class(es): Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	ICU Medical Inc.
Product Type:
FDA Application Number:	NDA016366
Marketing Category:	NDA
Start Marketing Date:	8/15/2019
End Marketing Date:	5/1/2022

Package Information

No.	Package Code	Package Description	Billing Unit
1	0990-7984-06	60 BAG in 1 CASE (0990-7984-06) / 50 mL in 1 BAG
2	0990-7984-11	60 BAG in 1 CASE (0990-7984-11) / 100 mL in 1 BAG	ML
3	0990-7984-13	48 POUCH in 1 CASE (0990-7984-13) / 1 BAG in 1 POUCH / 50 mL in 1 BAG	ML
4	0990-7984-20	12 POUCH in 1 CASE (0990-7984-20) / 4 BAG in 1 POUCH / 25 mL in 1 BAG	ML
5	0990-7984-23	48 POUCH in 1 CASE (0990-7984-23) / 1 BAG in 1 POUCH / 100 mL in 1 BAG	ML
6	0990-7984-36	20 POUCH in 1 CASE (0990-7984-36) / 4 BAG in 1 POUCH / 50 mL in 1 BAG	ML
7	0990-7984-37	20 POUCH in 1 CASE (0990-7984-37) / 4 BAG in 1 POUCH / 100 mL in 1 BAG	ML

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	0990-7984	The 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 NAME	Sodium Chloride	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	8/15/2019	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	NDA	Product 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 NUMBER	NDA016366	This 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 NAME	ICU Medical Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC	0990-7984	The 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 NAME	Sodium Chloride	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	4/1/2019	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	NDA	Product 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 NUMBER	NDA016366	This 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 NAME	ICU Medical Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/19/2025

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