Prescription drug · NDA
Monoferric (Ferric derisomaltose) NDC 73594-9301
Ferric derisomaltose 100 mg/mL · Injection, Solution · Intravenous · Pharmacosmos Therapeutics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73594-9301-2 | 73594930102 | 5 VIAL in 1 BOX (73594-9301-2) / 1 mL in 1 VIAL (73594-9301-3)Marketed from Jan 16, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Monoferric
- Generic name (nonproprietary)
- ferric derisomaltose
- Active ingredients
- Ferric derisomaltose — 100 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Pharmacosmos Therapeutics Inc.NDC labeler code 73594
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208171
- Marketing start
- Listing expires
- Identifiers
- Product ID 73594-9301_ddb3125c-a423-4256-9017-6e614ae2263dSPL ID ddb3125c-a423-4256-9017-6e614ae2263dSPL set ID 55859d2d-0456-4fa9-b41f-f535accc97dbRxCUI 2274398, 2274403, 2274406, 2274407, 2274408, 2274409UNII AHU547PI9HUPC 0373594931013
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
N473594930102followed by a unit qualifier and the quantityPackage 73594-9301-02. 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 .
Indications (excerpt from the label)
Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron who have non-hemodialysis dependent chronic kidney disease (NDD-CKD) MONOFERRIC is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron. ( 1 ) who have non-hemodialysis dependent chronic kidney disease. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 73594-9301
- What is NDC 73594-9301?
- 73594-9301 is the product NDC for Monoferric (ferric derisomaltose), Ferric derisomaltose 100 mg/mL injection, solution, listed with the FDA by Pharmacosmos Therapeutics Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Monoferric (Ferric derisomaltose).
- What is the active ingredient?
- Ferric derisomaltose.
- Who is the labeler?
- Pharmacosmos Therapeutics Inc., NDC labeler code 73594. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Monoferric?
- 2 other product NDCs are listed under this name. See all Monoferric NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Monoferric products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Monoferricferric derisomaltose | Ferric derisomaltose 500 mg/5mL | Injection, SolutionIntravenous | Pharmacosmos Therapeutics Inc. | 73594-9305 | 73594-9305-01 |
| Monoferricferric derisomaltose | Ferric derisomaltose 1000 mg/10mL | Injection, SolutionIntravenous | Pharmacosmos Therapeutics Inc. | 73594-9310 | 73594-9310-01 |
Other NDCs under NDA 208171
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 |
|---|---|---|---|---|
| Monoferricferric derisomaltose | Ferric derisomaltose 500 mg/5mL | Injection, SolutionIntravenous | Pharmacosmos Therapeutics Inc. | 73594-9305 |
| Monoferricferric derisomaltose | Ferric derisomaltose 1000 mg/10mL | Injection, SolutionIntravenous | Pharmacosmos Therapeutics Inc. | 73594-9310 |