sapropterin dihydrochloride
- Product NDC
- 49884-720
- 11-digit product format
- 498840720
- Labeler code
- 49884
- Product ID
- 49884-720_613f1a86-4523-4a35-ad6b-38ef403f7971
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sapropterin dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Par Health USA, LLC
- Application
- ANDA207200
- Marketing category
- ANDA
- Marketing start
- 2020-10-01
- 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 | 1486687 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49884-720-08 | sapropterin dihydrochloride | 120 in 1 BOTTLE | TABLET | 120 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-720 | SAPROPTERIN DIHYDROCHLORIDE TABLET [ENDO USA, INC.] | 14 | Current NDC, Legacy NDC, 1 package rows | 20240820_eafec3a2-4f29-4afa-8728-a62b34cefd18.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49884-720-08 | 49884072008 | 120 TABLET in 1 BOTTLE (49884-720-08) | 120 tablet | 2020-10-01 | 0000-00-00 | No | No | Current |