Prescription drug · ANDA
Sapropterin Dihydrochloride NDC 49884-948
Sapropterin dihydrochloride 100 mg/1 · Powder, For solution · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-948-72 | 4988409487249884094872 | 30 PACKET in 1 CARTON (49884-948-72) / 1 POWDER, FOR SOLUTION in 1 PACKET (49884-948-52)Marketed from Oct 1, 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)
- Sapropterin Dihydrochloride
- Generic name (nonproprietary)
- sapropterin dihydrochloride
- Active ingredients
- Sapropterin dihydrochloride — 100 mg/1
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Par Health USA, LLCNDC labeler code 49884
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207207
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Phenylalanine Hydroxylase Activators (Mechanism)
- Identifiers
- Product ID 49884-948_a5e80731-b1bc-4c44-9cfb-0c4c80eb1b0fSPL ID a5e80731-b1bc-4c44-9cfb-0c4c80eb1b0fSPL set ID 6b2172e4-42fc-42fe-b1ad-9d6a974d4343RxCUI 1111018UNII RG277LF5B3UPC 0349884948726
- 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
N449884094872followed by a unit qualifier and the quantityPackage 49884-0948-72. 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)
Sapropterin dihydrochloride powder for oral solution 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). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe-restricted diet. Sapropterin dihydrochloride powder for oral solution 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). Sapropterin di…
Excerpt only. Read the full label for complete information.
About NDC 49884-948
- What is NDC 49884-948?
- 49884-948 is the product NDC for Sapropterin Dihydrochloride, Sapropterin dihydrochloride 100 mg/1 powder, for solution, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sapropterin Dihydrochloride.
- What is the active ingredient?
- Sapropterin dihydrochloride.
- Who is the labeler?
- Par Health USA, LLC, NDC labeler code 49884. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sapropterin Dihydrochloride?
- 14 other product NDCs are listed under this name. See all Sapropterin Dihydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sapropterin Dihydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sapropterin Dihydrochloride | Sapropterin dihydrochloride 100 mg/1 | Powder, For solutionOral | Micro Labs Limited | 42571-509 | 42571-0509-41 |
| Sapropterin Dihydrochloride | Sapropterin dihydrochloride 500 mg/1 | Powder, For solutionOral | Micro Labs Limited | 42571-510 | 42571-0510-41 |
| Sapropterin Dihydrochloride | Sapropterin dihydrochloride 100 mg/1 | Powder, For solutionOral | TRUPHARMA, LLC | 52817-850 | 52817-0850-0152817-0850-30 |
| Sapropterin Dihydrochloride | Sapropterin dihydrochloride 500 mg/1 | Powder, For solutionOral | TRUPHARMA, LLC | 52817-851 | 52817-0851-0152817-0851-30 |
| sapropterin dihydrochloride | Sapropterin dihydrochloride 100 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0906 | 00054-0906-23 |
| Sapropterin Dihydrochloride | Sapropterin dihydrochloride 100 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-574 | 59651-0574-0859651-0574-2459651-0574-30 |
| sapropterin dihydrochloride | Sapropterin dihydrochloride 100 mg/1 | TabletOral | NorthStar RxLLC | 72603-191 | 72603-0191-01 |
| Sapropterin dihydrochloride | Sapropterin dihydrochloride 100 mg/1 | Powder, For solutionOral | NorthStar RxLLC | 72603-193 | 72603-0193-30 |
| Sapropterin dihydrochloride | Sapropterin dihydrochloride 500 mg/1 | Powder, For solutionOral | NorthStar RxLLC | 72603-194 | 72603-0194-30 |
| sapropterin dihydrochloride | Sapropterin dihydrochloride 100 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-045 | 31722-0045-12 |