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Glycine 1.5 g/100mL Irrigant — NDC 00264-7390-60 package photo

Glycine 1.5 g/100mL Irrigant

by B. Braun Medical Inc. · 4 CONTAINER in 1 CASE (0264-7390-60) / 3000 mL in 1 CONTAINER
NDC 00264-7390-60
🏷️ FDA NDC (as labeled) 0264-7390-60 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 0264-7390-60
Product NDC 0264-7390
11-digit billing NDC 00264739060
NCPDP billing unit ML — per mL (volume)
RxCUI 310571
UNII TE7660XO1C
Application # NDA016784
SPL Set ID f4d83550-42de-44c7-b8d5-1d0debc6aec2
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-12-04
Route IRRIGATION
Dosage form IRRIGANT
Substance GLYCINE
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
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 0264-7390-60 — 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 → 00264-7390-60. 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.

🏭 Manufacturer & labeler

LabelerB. Braun Medical Inc.
Application holderB BRAUN MEDICAL INC
FDA applicationNDA016784 (NDA)
Labeler code00264
First marketedDec 2013
Product typeHuman Prescription Drug
Portfolio94 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.

🩺 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.

🧪 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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Glycine 1.5 g/100mLthis 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/100mL 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

🏛️
2013
On the market since
Dec 2013
📍
2026
Currently FDA-listed
13 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Glycine — the ingredient across all brands.

Top reported reactions

Nausea73
Parenteral Nutrition Associated Liver Disease50
Vomiting50
Pneumonia47
Pyrexia46
Diarrhoea43
Dyspnoea43

Reporter sex

1,043 reports

Serious outcomes

Death144
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 113 35
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00264-7390-60 You're viewing this 4 CONTAINER in 1 CASE (0264-7390-60) / 3000 mL in 1 CONTAINER 2013-12-04 Active

🧭 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 FDA registers it as 0264-7390-60, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00264-7390-60, written without dashes as 00264739060. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00264-7390-60, the first segment (00264) is the labeler code FDA assigned to B. Braun Medical Inc.; the middle segment (7390) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) identifies this exact package size and type. Together they name one specific package of one specific product.
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 B. Braun Medical Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
B. Braun 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.

📄 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 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage 18 words ▾

INDICATIONS AND USAGE 1.5% Glycine Irrigation USP is indicated as an irrigant during transurethral prostatic or bladder surgery.

⏱️ Dosage and Administration 63 words ▾

DOSAGE AND ADMINISTRATION As required for irrigation. 1.5% Glycine Irrigation USP should be administered only by the appropriate transurethral urologic instrumentation. It has been reported that absorption is significantly increased if the container is higher than 60 cm (24 inches) above the patient. This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS 1.5% Glycine Irrigation USP is not for injection. It is contraindicated in patients with anuria.

⚠️ Warnings 149 words ▾

WARNINGS Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction. The amount of fluid absorbed during a transurethral resection is a function of the volume and hydrostatic pressure of the irrigant used, the number and size of venous sinuses opened, and the duration of the procedure. Since irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes, any irrigation solution must be regarded as a systemic drug.

Absorption of large amounts of fluids containing glycine and the resultant osmotic diuresis may significantly affect cardiopulmonary and renal dynamics. Absorption of large amounts of irrigating solution can also result in pronounced hyponatremia and water intoxication. After opening container, the contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.

Discard unused portion of irrigating solution since it contains no preservative.

🤒 Adverse Reactions 81 words ▾

ADVERSE REACTIONS Adverse reactions may include fluid and electrolyte disorders such as acidosis, electrolyte loss, marked diuresis, urinary retention, edema and dehydration; cardiovascular/pulmonary disorders such as pulmonary congestion, hypotension, tachycardia, angina-like pain and thrombophlebitis; other possible reactions include visual disturbances, convulsions, nausea, vomiting, diarrhea, vertigo and urticaria. Literature includes reports on hyponatremia, hyperammonemia, transient blindness, coma (immediate or delayed), and digitalis toxicity in digitalized patients.

If an adverse reaction occurs, discontinue the irrigant and reevaluate the clinical status of the patient.

🧬 Clinical Pharmacology 79 words ▾

CLINICAL PHARMACOLOGY 1.5% Glycine Irrigation USP is nontoxic and nonhemolytic with a refractive index close to that of water. These properties make it useful as a urologic irrigating fluid, particularly during transurethral surgical procedures where the irrigant may be absorbed through cut venous sinuses. Systemically absorbed glycine is primarily metabolized by transamination to serine, and by deamination to ammonia which is normally removed by its conversion to urea.

A portion of the absorbed glycine is excreted by the kidneys.

📦 How Supplied / Storage and Handling 75 words ▾

HOW SUPPLIED 1.5% Glycine Irrigation USP is supplied sterile and nonpyrogenic in single-dose 3000 mL flexible irrigation containers packaged 4 per case. NDC REF Size 0264-7390-60 R8406 3000 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Do not warm container over 150°F (66°C).

📦 Storage and Handling 46 words ▾

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Do not warm container over 150°F (66°C).

📋 Description 151 words ▾

DESCRIPTION Each 100 mL contains: Glycine USP ..................................................................................... 1.5 g Water for Injection USP ................................................................... qs pH: 6.1 (4.5-6.5) Calculated Osmolarity: 200 mOsmol/liter The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Glycine USP NH 2 CH 2 COOH 75.07 1.5% Glycine Irrigation USP is a sterile, nonpyrogenic aqueous solution suitable for urologic irrigation. This solution is slightly hypotonic.

The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene.

The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

Not made with natural rubber latex, PVC or DEHP.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00264-7389-60 · B. 00264-7510-00 · B. →
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.