Sapropterin Dihydrochloride
- Product NDC
- 52817-850
- 11-digit product format
- 528170850
- Labeler code
- 52817
- Product ID
- 52817-850_4b1fe6f7-f641-ec9a-e063-6394a90a4e04
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sapropterin Dihydrochloride
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- TRUPHARMA, LLC
- Application
- ANDA216432
- Marketing category
- ANDA
- Marketing start
- 2026-01-30
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sapropterin Dihydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SAPROPTERIN DIHYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RG277LF5B3 |
| Rxcui | 1111018, 1653217 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52817-850-01 | Sapropterin Dihydrochloride | 1 in 1 POUCH | POWDER, FOR SOLUTION | 1 | | 2 |
| 52817-850-30 | Sapropterin Dihydrochloride | 30 in 1 CARTON | POWDER, FOR SOLUTION | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 52817-850-01 | 52817085001 | 1 POWDER, FOR SOLUTION in 1 POUCH (52817-850-01) | 2026-01-30 | No | No | Historical |
| 52817-850-30 | 52817085030 | 30 POWDER, FOR SOLUTION in 1 CARTON (52817-850-30) | 2026-01-30 | No | No | Historical |