Prescription drug · NDA
Ultravist (Iopromide) NDC 50419-344
Iopromide 300 mg/mL · Injection · Intra-arterial, Intravenous · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50419-344-05 | 50419034405 | 10 VIAL, GLASS in 1 CARTON (50419-344-05) / 50 mL in 1 VIAL, GLASSMarketed from Dec 30, 2009 | |
| 50419-344-10 | 50419034410 | 10 VIAL, GLASS in 1 CARTON (50419-344-10) / 100 mL in 1 VIAL, GLASSMarketed from Dec 30, 2009 | |
| 50419-344-12 | 50419034412 | 10 VIAL, GLASS in 1 CARTON (50419-344-12) / 125 mL in 1 VIAL, GLASSMarketed from Dec 30, 2009 | |
| 50419-344-15 | 50419034415 | 10 VIAL, GLASS in 1 CARTON (50419-344-15) / 150 mL in 1 VIAL, GLASSMarketed from Dec 30, 2009 | |
| 50419-344-21 | 50419034421 | 10 BOTTLE in 1 PACKAGE (50419-344-21) / 200 mL in 1 BOTTLEMarketed from Dec 30, 2009 | |
| 50419-344-23 | 50419034423 | 10 BOTTLE in 1 PACKAGE (50419-344-23) / 200 mL in 1 BOTTLEMarketed from May 4, 2018 | |
| 50419-344-32 | 50419034432 | 8 BOTTLE in 1 PACKAGE (50419-344-32) / 500 mL in 1 BOTTLEMarketed from Oct 11, 2015 | |
| 50419-344-58 | 50419034458 | 8 BOTTLE in 1 PACKAGE (50419-344-58) / 500 mL in 1 BOTTLEMarketed from Dec 30, 2009 | |
| 50419-344-65 | 50419034465 | 8 BOTTLE in 1 PACKAGE (50419-344-65) / 500 mL in 1 BOTTLEMarketed from May 4, 2018 | |
| 50419-344-91 | 50419034491 | 10 VIAL, GLASS in 1 CARTON (50419-344-91) / 100 mL in 1 VIAL, GLASSMarketed from Oct 11, 2016 | |
| 50419-344-97 | 50419034497 | 8 BOTTLE in 1 PACKAGE (50419-344-97) / 500 mL in 1 BOTTLEMarketed from Oct 11, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ultravist
- Generic name (nonproprietary)
- iopromide
- Active ingredients
- Iopromide — 300 mg/mL
- Dosage form
- Injection
- Route
- Intra-arterial, Intravenous
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020220
- Marketing start
- Listing expires
- Other FDA classes
- X-Ray Contrast Activity (Mechanism)
- Identifiers
- Product ID 50419-344_4314fa34-edbc-44f3-b40b-277c6fbd2ab0SPL ID 4314fa34-edbc-44f3-b40b-277c6fbd2ab0SPL set ID df917c3a-59a2-4ed1-8470-8a5394c73325UNII 712BAC33MZUPC 0350419344654
- Pharmacologic class
- Radiographic Contrast Agent
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N450419034405followed by a unit qualifier and the quantityPackage 50419-0344-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
ULTRAVIST ® Injection is an iodinated contrast agent indicated for: ULTRAVIST is a radiographic contrast agent indicated for: Intra-Arterial Procedures † • Cerebral arteriography and peripheral arteriography in adults ( 1.1 ) • Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults ( 1.1 ) • Radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older ( 1.1 ) Intravenous Procedures † • Excretory urography in adults and pediatric patients aged 2 years and older ( 1.2 ) • Contrast computed tomography (CT) of head and body in adults and pediatric patients aged 2 years and older ( 1.2 ) • Contrast mammogr…
Excerpt only. Read the full label for complete information.
About NDC 50419-344
- What is NDC 50419-344?
- 50419-344 is the product NDC for Ultravist (iopromide), Iopromide 300 mg/mL injection, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 11 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ultravist (Iopromide).
- What is the active ingredient?
- Iopromide.
- Who is the labeler?
- Bayer HealthCare Pharmaceuticals Inc., NDC labeler code 50419. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ultravist?
- 3 other product NDCs are listed under this name. See all Ultravist NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ultravist products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ultravistiopromide | Iopromide 300 mg/mL | InjectionIntra-arterial, Intravenous | Bayer HealthCare Pharmaceuticals Inc. | 50419-347 | 50419-0347-0550419-0347-20 |
| Ultravistiopromide | Iopromide 370 mg/mL | InjectionIntra-arterial, Intravenous | Bayer HealthCare Pharmaceuticals Inc. | 50419-348 | 50419-0348-0550419-0348-1050419-0348-11+4 more |
| Ultravistiopromide | Iopromide 370 mg/mL | InjectionIntra-arterial, Intravenous | Bayer HealthCare Pharmaceuticals Inc. | 50419-346 | 50419-0346-0550419-0346-1050419-0346-15+7 more |
Other NDCs under NDA 020220
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ultravistiopromide | Iopromide 370 mg/mL | InjectionIntra-arterial, Intravenous | Bayer HealthCare Pharmaceuticals Inc. | 50419-346 |
| Ultravistiopromide | Iopromide 300 mg/mL | InjectionIntra-arterial, Intravenous | Bayer HealthCare Pharmaceuticals Inc. | 50419-347 |
| Ultravistiopromide | Iopromide 370 mg/mL | InjectionIntra-arterial, Intravenous | Bayer HealthCare Pharmaceuticals Inc. | 50419-348 |