Prescription drug · NDA
Kuvan (Sapropterin dihydrochloride) NDC 68135-482
Sapropterin dihydrochloride 500 mg/1 · Powder, For solution · Oral · BioMarin Pharmaceutical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68135-482-11 | 6813504821168135048211 | 30 PACKET in 1 CARTON (68135-482-11) / 1 POWDER, FOR SOLUTION in 1 PACKET (68135-482-10)Marketed from May 27, 2015 |
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)
- Kuvan
- Generic name (nonproprietary)
- sapropterin dihydrochloride
- Active ingredients
- Sapropterin dihydrochloride — 500 mg/1
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- BioMarin Pharmaceutical Inc.NDC labeler code 68135
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205065
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Phenylalanine Hydroxylase Activators (Mechanism)
- Identifiers
- Product ID 68135-482_c4286a54-6e01-4444-94a0-943411790e1dSPL ID c4286a54-6e01-4444-94a0-943411790e1dSPL set ID af38711e-8873-4790-a92d-4d583e23fb89RxCUI 1111018, 1111020, 1486687, 1486691, 1653217, 1653221UNII RG277LF5B3
- Pharmacologic class
- Phenylalanine Hydroxylase Activator
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
N468135048211followed by a unit qualifier and the quantityPackage 68135-0482-11. 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)
KUVAN ® is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). KUVAN is to be used in conjunction with a Phe-restricted diet. KUVAN is a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin‑ (BH4‑) responsive Phenylketonuria (PKU). KUVAN is to be used in conjunction with a Phe‑restricted diet. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 68135-482
- What is NDC 68135-482?
- 68135-482 is the product NDC for Kuvan (sapropterin dihydrochloride), Sapropterin dihydrochloride 500 mg/1 powder, for solution, listed with the FDA by BioMarin Pharmaceutical Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kuvan (Sapropterin dihydrochloride).
- What is the active ingredient?
- Sapropterin dihydrochloride.
- Who is the labeler?
- BioMarin Pharmaceutical Inc., NDC labeler code 68135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kuvan?
- 2 other product NDCs are listed under this name. See all Kuvan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Kuvan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Kuvansapropterin dihydrochloride | Sapropterin dihydrochloride 100 mg/1 | Powder, For solutionOral | BioMarin Pharmaceutical Inc. | 68135-301 | 68135-0301-22 |
| Kuvansapropterin dihydrochloride | Sapropterin dihydrochloride 100 mg/1 | TabletOral | BioMarin Pharmaceutical Inc. | 68135-300 | 68135-0300-02 |
Other NDCs under NDA 205065
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 |
|---|---|---|---|---|
| Kuvansapropterin dihydrochloride | Sapropterin dihydrochloride 100 mg/1 | Powder, For solutionOral | BioMarin Pharmaceutical Inc. | 68135-301 |