sapropterin dihydrochloride
- Product NDC
- 0054-0906
- 11-digit product format
- 000540906
- Labeler code
- 0054
- Product ID
- 0054-0906_d61800d3-94cc-46ce-8687-b467c63ac9fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sapropterin dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA218797
- Marketing category
- ANDA
- Marketing start
- 2025-10-23
- Substance
- SAPROPTERIN DIHYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- sapropterin dihydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SAPROPTERIN DIHYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RG277LF5B3 |
| Rxcui | 1486687 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0906-23 | sapropterin dihydrochloride | 120 in 1 BOTTLE | TABLET | 120 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0054-0906-23 | 00054090623 | 120 TABLET in 1 BOTTLE (0054-0906-23) | 120 tablet | 2025-10-23 | No | No | Historical |