Glycine

Product NDC
0990-7974
11-digit product format
009907974
Labeler code
0990
Product ID
0990-7974_3a1d66ff-c0ec-45f7-8c0a-df8dbc7f0cf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYCINE
Dosage form
IRRIGANT
Route
IRRIGATION
Labeler
ICU Medical Inc.
Application
NDA018315
Marketing category
NDA
Marketing start
2019-07-01
Substance
GLYCINE
Active strength
1.5 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Glycine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCINE1.5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTE7660XO1C
Rxcui310571

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0990-7974-08Glycine4 in 1 CASEIRRIGANT48
0990-7974-08Glycine1 in 1 POUCHIRRIGANT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0990-7974-08ML - Milliliter0990-79748f3c9366-f88d-4c88-830f-dcf410f0adae12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0990-7974GLYCINE IRRIGANT [ICU MEDICAL INC.]6Current NDC, Legacy NDC, 2 package rows20230421_c10a4657-cf64-4a71-a247-363dd58993bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310571glycine 1.5 % Irrigation SolutionPSNc10a4657-cf64-4a71-a247-363dd58993bc8
310571glycine 15 MG/ML Irrigation SolutionSCDc10a4657-cf64-4a71-a247-363dd58993bc8
310571glycine 1.5 % Irrigation SolutionSYc10a4657-cf64-4a71-a247-363dd58993bc8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0990-7974-08009907974084 POUCH in 1 CASE (0990-7974-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG4 pouch2019-07-010000-00-00NoNoCurrent