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NDC 72603-0194-30 Sapropterin dihydrochloride 500 mg/1 Details
Sapropterin dihydrochloride 500 mg/1
Sapropterin dihydrochloride is a ORAL POWDER, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by NorthStar RxLLC. The primary component is SAPROPTERIN DIHYDROCHLORIDE.
MedlinePlus Drug Summary
Sapropterin is used along with a restricted diet to control blood phenylalanine levels in adults and children 1 month of age and older who have phenylketonuria (PKU; an inborn condition in which phenylalanine may build up in the blood and causes decreased intelligence and a decreased ability to focus, remember, and organize information). Sapropterin will only work for some people who have PKU, and the only way to tell if sapropterin will help a particular patient is to give the medication for a period of time and see whether his or her phenylalanine level decreases. Sapropterin is in a class of medications called cofactors. It works by helping the body to break down phenylalanine so it will not build up in the blood.
Related Packages: 72603-0194-30Last Updated: 05/19/2024
MedLinePlus Full Drug Details: Sapropterin
Product Information
| NDC | 72603-0194 |
|---|---|
| Product ID | 72603-194_0bada422-a189-3871-e063-6294a90a0008 |
| Associated GPIs | |
| GCN Sequence Number | 074256 |
| GCN Sequence Number Description | sapropterin dihydrochloride POWD PACK 500 MG ORAL |
| HIC3 | C7H |
| HIC3 Description | PKU TX AGENT-COFACTOR OF PHENYLALANINE HYDROXYLASE |
| GCN | 38845 |
| HICL Sequence Number | 035266 |
| HICL Sequence Number Description | SAPROPTERIN DIHYDROCHLORIDE |
| Brand/Generic | Generic |
| Proprietary Name | Sapropterin dihydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sapropterin dihydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER, FOR SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | SAPROPTERIN DIHYDROCHLORIDE |
| Labeler Name | NorthStar RxLLC |
| Pharmaceutical Class | Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA215420 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 72603-0194-30 (72603019430)
| NDC Package Code | 72603-194-30 |
|---|---|
| Billing NDC | 72603019430 |
| Package | 30 PACKET in 1 CARTON (72603-194-30) / 1 POWDER, FOR SOLUTION in 1 PACKET |
| Marketing Start Date | 2023-12-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |