Sapropterin Dihydrochloride
- Product NDC
- 43598-749
- 11-digit product format
- 435980749
- Labeler code
- 43598
- Product ID
- 43598-749_2607ac79-fdb9-4688-b322-0c351d8eb20e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sapropterin Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr. Reddys Laboratories Inc.
- Application
- NDA022181
- Marketing category
- NDA
- Marketing start
- 2020-10-01
- Marketing end
- 0000-00-00
- Substance
- SAPROPTERIN DIHYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Phenylalanine Hydroxylase Activator [EPC],Phenylalanine Hydroxylase Activators [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SAPROPTERIN DIHYDROCHLORIDE | 100 mg/1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43598-749-04 | 43598074904 | 1 BOTTLE in 1 CARTON (43598-749-04) > 120 TABLET in 1 BOTTLE | 1 bottle | 2020-10-01 | 0000-00-00 | No | No | Current |