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Glycine 1.5 g/100mL Irrigant — NDC 00990-7974-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Glycine 1.5 g/100mL Irrigant — NDC 0990-7974-08 (Billing 00990-7974-08)

by ICU Medical Inc. · 4 POUCH in 1 CASE / 1 BAG in 1 POUCH / 3000 mL in 1 BAG

This is a package of Glycine 1.5 g/100mL Irrigant from ICU Medical Inc., marketed since Jul 2019 and currently FDA-listed. It is this product's only package size.

NDC 00990-7974-08
🏷️ FDA NDC (as labeled) 0990-7974-08 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0990-7974-08
Product NDC 0990-7974
11-digit billing NDC 00990797408
NCPDP billing unit ML — per mL (volume)
RxCUI 310571
UNII TE7660XO1C
Application # NDA018315
SPL Set ID c10a4657-cf64-4a71-a247-363dd58993bc
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-07-01
Route IRRIGATION
Dosage form IRRIGANT
Substance GLYCINE
TE code (Orange Book) AT · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 56700050002005
GPI class Glycine
GCN Seq No 009879
GCN 45760
HICL code 004306
Ingredient (HICL) Glycine Urologic Solution
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W8
Therapeutic class — intermediate (HIC2) Antiseptics
HIC3 code W8J
Therapeutic class — specific (HIC3) Antibacterial Agents,Miscellaneous
AHFS code 40:36.00.00
AHFS class Irrigating Solutions
FDB label name GLYCINE 1.5% IRRIGATION
FDB brand name Glycine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009879
  • GCN: 45760
  • GPI-14 (Medi-Span): 56700050002005
  • HICL (First Databank): 004306
  • AHFS class code: 40:36.00.00
  • RxCUI (RxNorm): 310571
Why two NDCs? The FDA registers this code as 0990-7974-08 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00990-7974-08. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other irrigating solutions class.

Drug family (ATC) Other irrigating solutions
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name GLYCINE 1.5% IRRIGATION Ingredient Glycine Urologic Solution
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00990-7974-08 You're viewing this Main listing 4 POUCH in 1 CASE / 1 BAG in 1 POUCH / 3000 mL in 1 BAG 2019-07-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Glycine 1.5 g/100mL 00264-7390-60 B. 3000 ml — AT FDA listed —
Glycine 1.5 g/100mL 00338-0289-47 Baxter 3000 ml — AT FDA listed —
Glycine 1.5 g/100mLthis 00990-7974-08 ICU 4 pouches — AT FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Jul 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerICU Medical Inc.
Application holderOTSUKA ICU MEDICAL LLC
FDA applicationNDA018315 (NDA)
Labeler code00990
First marketedJul 2019
Product typeHuman Prescription Drug
Portfolio48 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 23 words ▾

INDICATIONS AND USAGE 1.5% Glycine Irrigation, USP is indicated for use as irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.

⏱️ Dosage and Administration 111 words ▾

DOSAGE AND ADMINISTRATION 1.5% Glycine Irrigation, USP should be administered only by transurethral instillation with appropriate urologic instrumentation. A disposable irrigation set should be used. The total volume of solution used for irrigation is solely at the discretion of the surgeon.

Height of container(s) above the operating table in excess of 60 cm (approx. 2 ft.) has been reported to increase intravascular absorption of the irrigating fluid. Drug Interactions Additives may be incompatible.

Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits.

See PRECAUTIONS.

⛔ Contraindications 15 words ▾

CONTRAINDICATIONS NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. Do not use in patients with anuria.

⚠️ Warnings 73 words ▾

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 137 words ▾

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.

🤰 Pregnancy 55 words ▾

Pregnancy: Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with Glycine Irrigation, USP. It is also not known whether Glycine Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Glycine Irrigation, USP should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 31 words ▾

Pediatric Use: The safety and effectiveness of Glycine Irrigation have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

🆘 Overdosage 23 words ▾

OVERDOSAGE In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.

🧬 Clinical Pharmacology 214 words ▾

CLINICAL PHARMACOLOGY Glycine is an amino acid and a nonelectrolyte. A solution of glycine in water is therefore nonconductive and suitable for urologic irrigation during electrosurgical procedures. A 1.5% concentration of glycine in water (200 mOsmol/liter calc.) is sufficient to minimize the risk of intravascular hemolysis which can occur from absorption of plain water through open prostatic veins during transurethral resection (TUR).

It is hypotonic in relation to the extracellular fluid (280 mOsmol/liter). Any solution absorbed intravascularly during transurethral prostatic or bladder surgery, although variable in amount depending primarily on the extent of surgery, will be excreted by the kidney. Studies have shown that the absorption of glycine does not cause significant hemolysis (increase of free hemoglobin) or release significant amounts of free ammonia in the blood.

Glycine is rapidly degraded in the liver by glycine oxidase. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium.

📦 How Supplied / Storage and Handling 104 words ▾

HOW SUPPLIED 1.5% Glycine Irrigation, USP is supplied in single-dose 3000 mL flexible irrigation container NDC No. Product Container Size (mL) 0409-7974-08 1.5% Glycine Irrigation, USP 3000 mL 0990-7974-08 1.5% Glycine Irrigation, USP 3000 mL ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: November, 2022 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA IFU0000478

📋 Description ~1 min read ▾

DESCRIPTION 1.5% Glycine Irrigation, USP is a sterile, nonpyrogenic, hypotonic, aqueous solution of glycine intended only for urologic irrigation during transurethral surgical procedures. Each 100 mL contains 1.5 g of glycine in water for injection. The solution is nonelectrolytic, hypotonic and has an osmolarity of 200 mOsmol/liter (calc.); pH 6.0 (4.5 to 6.5).

The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose irrigation. When smaller volumes are required, the unused portion should be discarded. 1.5% Glycine Irrigation is a urologic nonelectrolyte irrigant.

Glycine, USP is chemically designated aminoacetic acid (C 2 H 5 NO 2 ), a white crystalline powder freely soluble in water. It has the following structural formula: NH 2 CH 2 COOH Water for Injection, USP is chemically designated H 2 0. The flexible plastic container is fabricated from a specially formulated polyvinylchloride.

Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene.

The container requires no vapor barrier to maintain the proper drug concentration. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.

Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses.

It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

⚠️ Precautions ~1 min read ▾

PRECAUTIONS Cardiovascular status, especially of the patient with cardiac disease, should be carefully observed before and during transurethral resection of the prostate when using glycine irrigating solution, because the quantity of fluid absorbed into the systemic circulation by opened prostatic veins may produce significant expansion of the extracellular fluid and lead to fulminating congestive heart failure. Shift of sodium free intracellular fluid into the extracellular compartment following systemic absorption of solution may lower serum sodium concentration and aggravate pre-existing hyponatremia.

Care should be exercised if impaired liver function is known or suspected. Under such conditions, ammonia resulting from metabolism of glycine may accumulate in the blood. Aseptic technique is essential with the use of sterile solutions for irrigation.

The administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start-up of each cycle or repeat procedure. Do not administer unless solution is clear, seal is intact and container is undamaged.

Discard unused portion. Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Glycine Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. Nursing Mothers: Caution should be exercised when Glycine Irrigation, USP is administered to a nursing woman.

Pregnancy: Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with Glycine Irrigation, USP.

It is also not known whether Glycine Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Glycine Irrigation, USP should be given to a pregnant woman only if clearly needed. Pediatric Use: The safety and effectiveness of Glycine Irrigation have not been established.

Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

🍼 Nursing Mothers 16 words ▾

Nursing Mothers: Caution should be exercised when Glycine Irrigation, USP is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 24 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Glycine Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

📄 Package Label / Principal Display Panel 170 words ▾

PRINCIPAL DISPLAY PANEL - 3000 mL Bag Label 3000 mL NDC 0990-7974-08 1.5% GLYCINE IRRIGATION, USP EACH 100 mL CONTAINS GLYCINE (AMINOACETIC ACID) 1.5 g. pH 6.0 (4.5 TO 6.5) 200 mOsmol/LITER (CALC.) STERILE, NONPYROGENIC, HYPOTONIC. INDICATIONS: FOR UROLOGIC IRRIGATION. CONTRAINDICATIONS: NOT FOR INJECTION.

USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. WARNINGS: DO NOT HEAT OVER 66°C (150°F) OR STORE ABOVE 40°C (104°F). SINGLE-DOSE CONTAINER.

CONTAINS NO BACTERIOSTAT. DISCARD UNUSED PORTION. USE ASEPTIC TECHNIQUE.

USUAL DOSAGE: SEE INSERT. RX ONLY 3 V CONTAINS DEHP IM-4381 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icumedical PRINCIPAL DISPLAY PANEL - 3000 mL Bag Label

PRINCIPAL DISPLAY PANEL - Overwrap Label 2 HDPE TO OPEN TEAR AT NOTCH DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY. IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. SEE INSERT. 98-4321-R14-3/98 PRINCIPAL DISPLAY PANEL - Overwrap Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by ICU Medical Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ICU Medical Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00990-7973-05 · ICU 00990-7981-08 · ICU →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.