Prescription drug · ANDA
Javygtor (Sapropterin dihydrochloride) NDC 43598-096
Sapropterin dihydrochloride 100 mg/1 · Tablet · Oral · Dr. Reddys Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-096-04 | 4359800960443598009604 | 120 TABLET in 1 BOTTLE (43598-096-04)Marketed from Oct 3, 2022 | |
| 43598-096-05 | 4359800960543598009605 | 500 TABLET in 1 BOTTLE (43598-096-05)Marketed from Oct 3, 2022 | |
| 43598-096-30 | 4359800963043598009630 | 30 TABLET in 1 BOTTLE (43598-096-30)Marketed from Oct 3, 2022 |
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)
- Javygtor
- Generic name (nonproprietary)
- sapropterin dihydrochloride
- Active ingredients
- Sapropterin dihydrochloride — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Dr. Reddys Laboratories IncNDC labeler code 43598
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207685
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Phenylalanine Hydroxylase Activators (Mechanism)
- Identifiers
- Product ID 43598-096_ce2e0e3a-40e4-33ed-3cad-e166dd2245a1SPL ID ce2e0e3a-40e4-33ed-3cad-e166dd2245a1SPL set ID d9f3723f-bf7d-9a72-2ef9-41c5508d6ab4RxCUI 1486687, 2612671UNII RG277LF5B3UPC 0343598096049
- 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
N443598009604followed by a unit qualifier and the quantityPackage 43598-0096-04. 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)
JAVYGTOR (sapropterin dihydrochloride) 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). JAVYGTOR is to be used in conjunction with a Phe-restricted diet. JAVYGTOR (sapropterin dihydrochloride) 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). JAVYGTOR is to be used in conjunction with a Phe-restricted diet. ( 1 )…
Excerpt only. Read the full label for complete information.
About NDC 43598-096
- What is NDC 43598-096?
- 43598-096 is the product NDC for Javygtor (sapropterin dihydrochloride), Sapropterin dihydrochloride 100 mg/1 tablet, listed with the FDA by Dr. Reddys Laboratories Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Javygtor (Sapropterin Dihydrochloride).
- What is the active ingredient?
- Sapropterin dihydrochloride.
- Who is the labeler?
- Dr. Reddys Laboratories Inc, NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Javygtor?
- 2 other product NDCs are listed under this name. See all Javygtor NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Javygtor products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Javygtorsapropterin dihydrochloride | Sapropterin dihydrochloride 500 mg/1 | Powder, For solutionOral | Dr. Reddys Laboratories Inc | 43598-162 | 43598-0162-30 |
| Javygtorsapropterin dihydrochloride | Sapropterin dihydrochloride 100 mg/1 | Powder, For solutionOral | Dr. Reddys Laboratories Inc | 43598-097 | 43598-0097-30 |