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Cystografin diatrizoate meglumine 300 mg/mL Injection, Solution — NDC 00270-0149-57 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cystografin diatrizoate meglumine 300 mg/mL Injection, Solution — NDC 0270-0149-57 (Billing 00270-0149-57)

by BRACCO DIAGNOSTICS INC · 10 BOTTLE in 1 PACKAGE / 300 mL in 1 BOTTLE

This is a package of Cystografin diatrizoate meglumine 300 mg/mL Injection, Solution from BRACCO DIAGNOSTICS INC, marketed since Nov 1970 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00270-0149-57
🏷️ FDA NDC (as labeled) 0270-0149-57 billing pads the labeler segment with a zero
This package
Contains300 mL in 1 bottle Pack sizes2 compare ↓
Main listing for product 0270-0149 · Also comes in: 10 bottles 0270-0149-60
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 0270-0149-57 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0270 labeler · 0149 product · 57 package
Package marketed since
Nov 3, 1970
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0270014957 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0270-0149-57
Product NDC 0270-0149
11-digit billing NDC 00270014957
NCPDP billing unit ML — per mL (volume)
UNII 3X9MR4N98U
Application # NDA010040
SPL Set ID 7496d736-9f7d-4136-ad5d-b24c7803c21b
Established class (EPC) Radiographic Contrast Agent
Mechanism of action X-Ray Contrast Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1970-11-03
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance DIATRIZOATE MEGLUMINE

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

GPI-14 94402015102011
GPI class Cystografin
GCN Seq No 008273
GCN 35235
HICL code 003694
Ingredient (HICL) Diatrizoate Meglumine
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R2
Therapeutic class — intermediate (HIC2) Urinary Tract Diagnostics
HIC3 code R2U
Therapeutic class — specific (HIC3) Urinary Tract Radiopaque Diagnostics
AHFS code 36:68.00.00
AHFS class Roentgenography And Other Imaging Agents
FDB label name CYSTOGRAFIN 30% INFUS. BTL
FDB brand name Cystografin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 008273
  • GCN: 35235
  • GPI-14 (Medi-Span): 94402015102011
  • HICL (First Databank): 003694
  • AHFS class code: 36:68.00.00
Why two NDCs? The FDA registers this code as 0270-0149-57 — 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 → 00270-0149-57. 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.

Clinical

Label name CYSTOGRAFIN 30% INFUS. BTL Ingredient Diatrizoate Meglumine
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 mLPer 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.
Medicare Part B allowsASP · Q9958 $0.077 / Q9958 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)0270-0149-57
11-digit billing NDC00270-0149-57
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeQ9958
DescriptorHigh osmolar contrast material, up to 149 mg/ml iodine concentration, per ml
Billing units / pkg3,000 units
How the units are derivedThis package is 300; the HCPCS unit is 1 ML, so one package = 3000 billing units.
Medicare Part B spend (2026 (Q1))$3,291 · 249 claims · $13.22 per claim (all NDCs under Q9958)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00270-0149-57 You're viewing this Main listing 10 BOTTLE in 1 PACKAGE / 300 mL in 1 BOTTLE 1970-11-03 — Active
00270-0149-60 0270-0149-60 10 BOTTLE in 1 PACKAGE / 100 mL in 1 BOTTLE 1970-11-03 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 10 bottle in 1 package / 300 ml in 1 bottle.
What NDC number is used to bill for this package of Cystografin diatrizoate meglumine 300 mg/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cystografin 300 mg/mLthis 00270-0149-57 BRACCO 10 bottles — — 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

🏛️
1970
On the market since
Nov 1970
📍
2026
Currently FDA-listed
56 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.

  • 0.4 mg / 1 mL UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.

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

LabelerBRACCO DIAGNOSTICS INC
Application holderBRACCO DIAGNOSTICS INC
FDA applicationNDA010040 (NDA)
Labeler code00270
First marketedNov 1970
Product typeHuman Prescription Drug
Portfolio30 products on file

More NDCs from BRACCO DIAGNOSTICS INC labeler code 00270

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 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 7 words ▾

INDICATION Cystografin is indicated for retrograde cystourethrography.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Preparation of the patient: Appropriate preparation is desirable for optimal results. A laxative the night before the examination and a low residue diet the day before the procedure are recommended. Dosage: The dose for retrograde use in cystography and voiding cystourethrography ranges from 25 to 300 mL depending on the age of the patient and the degree of bladder irritability; amounts greater than 300 mL may be used if the bladder capacity allows.

Best results are obtained when the bladder is filled with the contrast agent. If desired, the preparation may be diluted with sterile water or sterile saline as indicated in the table below. Administration: After sterile catheterization, the bladder should be filled to capacity with Cystografin using a suitable sterile administration set.

Care should be taken to avoid using excessive pressure. The presence of bladder discomfort or reflux and/or spontaneous voiding usually indicates that the bladder is full. Radiography: The commonly employed radiographic techniques should be used.

A scout film is recommended before the contrast agent is administered. Dilution Table USE DILUTED SOLUTIONS IMMEDIATELY 100 mL Bottle Sterile Water or Sterile Saline Added % Diatrizoate Meglumine w/v % Organically Bound Iodine w/v Total Volume 0 mL 30.0 14.1 100 mL 25 mL 24.0 11.3 125 mL 50 mL 20.0 9.4 150 mL 67 mL 18.0 8.5 167 mL 300 mL Bottle Sterile Water or Sterile Saline Added 0 mL 30.0 14.1 300 mL 50 mL 25.7 12.1 350 mL

⛔ Contraindications 15 words ▾

CONTRAINDICATIONS This preparation is contraindicated in patients with a hypersensitivity to salts of diatrizoic acid.

⚠️ Warnings 59 words ▾

WARNINGS Severe sensitivity reactions are more likely to occur in patients with a personal or family history of bronchial asthma, significant allergies, or previous reactions to contrast agents. A history of sensitivity to iodine per se or to other contrast agents is not an absolute contraindication to the use of diatrizoate meglumine, but calls for extreme caution in administration.

🤒 Adverse Reactions 129 words ▾

ADVERSE REACTIONS Retrograde genitourinary procedures may cause such complications as hematuria, perforation of the urethra or bladder, introduction of infection into the genitourinary tract, and oliguria or anuria. If intravasation of this drug occurs, the reactions which may be associated with intravenous administration may possibly be encountered. Hypersensitivity or anaphylactoid reactions may occur.

Severe reactions may be manifested by edema of the face and glottis, respiratory distress, convulsions or shock; such reactions may prove fatal unless promptly controlled by such emergency measures as maintenance of a clear airway and immediate use of oxygen and resuscitative drugs. Endocrine: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and pediatric patients, including infants. Some patients were treated for hypothyroidism.

📦 How Supplied / Storage and Handling 71 words ▾

HOW SUPPLIED Cystografin (Diatrizoate Meglumine Injection USP 30%) is available in 200 mL and 400 mL bottles containing 100 mL and 300 mL of Cystografin respectively with sufficient capacity for dilution up to 167 mL and 350 mL respectively. Storage Store at 20-25°C (68-77°F) [See USP]. Protect from light. Also Available Cystografin Dilute (Diatrizoate Meglumine Injection USP 18%) is also available, as a 300 mL fill in a 400 mL bottle.

📦 Storage and Handling 10 words ▾

Storage Store at 20-25°C (68-77°F) [See USP]. Protect from light.

📋 Description 71 words ▾

DESCRIPTION Cystografin is a radiopaque contrast agent supplied as a sterile, clear, colorless to pale yellow, mobile or slightly viscous solution. Each mL provides 300 mg diatrizoate meglumine with 0.4 mg edetate disodium as a sequestering agent. Each mL of solution also contains approximately 141 mg organically bound iodine.

At the time of manufacture, the air in the container is replaced by nitrogen. The preparation should be protected from strong light.

⚠️ Precautions 143 words ▾

PRECAUTIONS Safe and effective use of this preparation depends upon proper dosage, correct technique, adequate precautions, and readiness for emergencies. Retrograde cystourethrography should be performed with caution in patients with a known active infectious process of the urinary tract. Sterile technique should be employed in administration.

During administration, care should be taken to avoid excessive pressure, rapid or acute distention of the bladder, and trauma. Contrast agents may interfere with some chemical determinations made on urine specimens; therefore, urine should be collected before administration of the contrast medium or two or more days afterwards. Pregnancy—Teratogenic Effects: Animal reproduction studies have not been conducted with diatrizoate meglumine injection.

It is also not known whether diatrizoate meglumine injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cystografin should be administered to a pregnant woman only if clearly needed.

📄 Package Label / Principal Display Panel 29 words ▾

Cystografin 100 mL Label NDC 0270-0149-60 Cystografin 1 Box 10 Bottles — 300 mL each NDC 0270-0149-57 Cystografin 100 mL Label Cystografin 1 Box 10 Bottles — 300 mL

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

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 Cystografin (this brand).

Top reported reactions

Nausea71
Pain68
Dyspnoea67
Rash67
Confusional State66
Pericarditis64
Psoriatic Arthropathy64

Age at onset

Adult36
Elderly2

Reporter sex

0 reports
Male · 22%
Female · 78%

Serious outcomes

Life-threatening87
Death87
Disabling82
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 58 3
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.

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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
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 BRACCO DIAGNOSTICS INC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 10 bottles (00270-0149-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
BRACCO DIAGNOSTICS 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code Q9958 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 00270-0091-01 · Bracco 00270-0445-35 · Bracco →
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.