Prescription drug · NDA
Siklos (Hydroxyurea) NDC 71770-105
Hydroxyurea 100 mg/1 · Tablet, Film coated · Oral · Medunik
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71770-105-60 | 71770010560 | 1 BOTTLE in 1 CARTON (71770-105-60) / 60 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 15, 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)
- Siklos
- Generic name (nonproprietary)
- hydroxyurea
- Active ingredients
- Hydroxyurea — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- MedunikNDC labeler code 71770
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208843
- Marketing start
- Listing expires
- Other FDA classes
- Urea (Chemical structure)
- Identifiers
- Product ID 71770-105_47d0b61d-ad65-d2e0-e063-6294a90afe50SPL ID 47d0b61d-ad65-d2e0-e063-6294a90afe50SPL set ID 76957c0d-0f98-4376-bb06-eee651adc09dRxCUI 283475, 1999308, 1999314, 1999316UNII X6Q56QN5QC
- Pharmacologic class
- Antimetabolite
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
N471770010560followed by a unit qualifier and the quantityPackage 71770-0105-60. 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)
SIKLOS ® is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises SIKLOS is an antimetabolite, indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 71770-105
- What is NDC 71770-105?
- 71770-105 is the product NDC for Siklos (hydroxyurea), Hydroxyurea 100 mg/1 tablet, film coated, listed with the FDA by Medunik. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Siklos (Hydroxyurea).
- What is the active ingredient?
- Hydroxyurea.
- Who is the labeler?
- Medunik, NDC labeler code 71770. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Siklos?
- 1 other product NDC are listed under this name. See all Siklos NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Siklos products
Other finished products listed under the same name: strengths, forms and labelers.
Other NDCs under NDA 208843
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.