Prescription drug · ANDA
Deferasirox oral NDC 67877-677
Deferasirox 360 mg/1 · Granule · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-677-84 | 6787706778467877067784 | 30 PACKET in 1 CARTON (67877-677-84) / 1 GRANULE in 1 PACKET (67877-677-73)Marketed from Jul 16, 2020 |
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)
- Deferasirox oral
- Generic name (nonproprietary)
- deferasirox oral
- Active ingredients
- Deferasirox — 360 mg/1
- Dosage form
- Granule
- Route
- Oral
- Labeler
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213374
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Iron Chelating Activity (Mechanism)
- Identifiers
- Product ID 67877-677_42f2152c-686d-4d31-af97-ce0dcb73b1f5SPL ID 42f2152c-686d-4d31-af97-ce0dcb73b1f5SPL set ID 2c2842a0-7781-4047-84cd-88bd018e10c7RxCUI 1923822, 1923826, 1923828UNII V8G4MOF2V9UPC 0367877675718, 0367877676722, 0367877677736
- Pharmacologic class
- Iron Chelator
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N467877067784followed by a unit qualifier and the quantityPackage 67877-0677-84. 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)
Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. ( 1.1 ) Deferasirox is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. ( 1.2 ) Limitations of Use: The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established. ( 1.3 ) 1.1 Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusion…
Excerpt only. Read the full label for complete information.
About NDC 67877-677
- What is NDC 67877-677?
- 67877-677 is the product NDC for Deferasirox oral, Deferasirox 360 mg/1 granule, listed with the FDA by Ascend Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Deferasirox oral.
- What is the active ingredient?
- Deferasirox.
- Who is the labeler?
- Ascend Laboratories, LLC, NDC labeler code 67877. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Deferasirox oral?
- 2 other product NDCs are listed under this name. See all Deferasirox oral NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Deferasirox oral products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Deferasirox oral | Deferasirox 90 mg/1 | GranuleOral | Ascend Laboratories, LLC | 67877-675 | 67877-0675-84 |
| Deferasirox oral | Deferasirox 180 mg/1 | GranuleOral | Ascend Laboratories, LLC | 67877-676 | 67877-0676-84 |
Other NDCs under ANDA 213374
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 |
|---|---|---|---|---|
| Deferasirox oral | Deferasirox 90 mg/1 | GranuleOral | Ascend Laboratories, LLC | 67877-675 |
| Deferasirox oral | Deferasirox 180 mg/1 | GranuleOral | Ascend Laboratories, LLC | 67877-676 |