Prescription drug · ANDA
sapropterin dihydrochloride NDC 0054-0906
Sapropterin dihydrochloride 100 mg/1 · Tablet · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0906-23 | 0005409062300054090623 | 120 TABLET in 1 BOTTLE (0054-0906-23)Marketed from Oct 23, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Tablet
- Route
- Oral
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218797
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Phenylalanine Hydroxylase Activators (Mechanism)
- Identifiers
- Product ID 0054-0906_a92c2177-440b-4da4-92f4-e8c809ac64c5SPL ID a92c2177-440b-4da4-92f4-e8c809ac64c5SPL set ID c4d92cce-e899-4f14-b19c-5e17f9922215RxCUI 1486687UNII 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
N400054090623followed by a unit qualifier and the quantityPackage 00054-0906-23. 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 tablets are 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 tablets are to be used in conjunction with a Phe- restricted diet. Sapropterin dihydrochloride tablets are 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 dihydrochloride tablets are to be used in conju…
Excerpt only. Read the full label for complete information.
About NDC 0054-0906
- What is NDC 0054-0906?
- 0054-0906 is the product NDC for sapropterin dihydrochloride, Sapropterin dihydrochloride 100 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. 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?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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 | 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 |
| Sapropterin dihydrochloride | Sapropterin dihydrochloride 100 mg/1 | Powder, For solutionOral | Camber Pharmaceuticals, Inc. | 31722-047 | 31722-0047-3031722-0047-31 |