Glycine
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Glycine
- Generic name
- GLYCINE
- Manufacturer
- ICU Medical Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- c10a4657-cf64-4a71-a247-363dd58993bc
- SPL ID
- fec5845c-710f-4a36-8d95-823471210c8a
- Version
- 9
- Effective date
- 2025-10-21
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:19:22
| Harmonized routes |
|---|
| IRRIGATION |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | NDA | 018315 | derived:openfda.application_number |
| application number | NDA018315 | openfda.application_number | |
| brand name | Glycine | openfda.brand_name | |
| generic name | GLYCINE | openfda.generic_name | |
| manufacturer name | ICU Medical Inc. | openfda.manufacturer_name | |
| ndc | package | 0990-7974-08 | openfda.package_ndc |
| ndc | product | 0990-7974 | openfda.product_ndc |
| ndc11 | package | 00990797408 | derived:openfda.package_ndc |
| rxcui | 310571 | openfda.rxcui | |
| spl id | fec5845c-710f-4a36-8d95-823471210c8a | id | |
| spl set id | c10a4657-cf64-4a71-a247-363dd58993bc | set_id | |
| unii | TE7660XO1C | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS FOR UROLOGIC IRRIGATION ONLY. Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction. Irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes. Thus, glycine irrigating solution must be regarded as a systemic drug. Absorption of large amounts of fluids containing glycine may significantly alter cardiopulmonary and renal dynamics. Do not heat container over 66°C (150°F).
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Adverse reactions may result from intravascular absorption of glycine. Large intravenous doses of glycine are known to cause salivation, nausea and lightheadedness. Other consequences of absorption of urologic irrigating solutions include fluid and electrolyte disturbances such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema, dryness of mouth, thirst, dehydration, coma from hyponatremia, secondary hyponatremia due to fluid overload, and hyperammonemia with resultant coma and/or encephalopathy; cardiovascular disorders such as hypotension, tachycardia, angina-like pains; pulmonary disorders such as pulmonary congestion; and other general reactions such as blurred vision, convulsions, nausea, vomiting, rhinitis, chills, vertigo, backache, transient blindness and urticaria. Allergic reactions from glycine are unknown or exceedingly rare. Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.