SAPROPTERIN DIHYDROCHLORIDE
- Product NDC
- 49884-948
- 11-digit product format
- 498840948
- Labeler code
- 49884
- Product ID
- 49884-948_a5e80731-b1bc-4c44-9cfb-0c4c80eb1b0f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SAPROPTERIN DIHYDROCHLORIDE
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Par Health USA, LLC
- Application
- ANDA207207
- 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 | 1111018 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49884-948-52 | SAPROPTERIN DIHYDROCHLORIDE | 1 in 1 PACKET | POWDER, FOR SOLUTION | 1 | | 14 |
| 49884-948-72 | SAPROPTERIN DIHYDROCHLORIDE | 30 in 1 CARTON | POWDER, FOR SOLUTION | 30 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-948 | SAPROPTERIN DIHYDROCHLORIDE POWDER, FOR SOLUTION [ENDO USA, INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20240713_6b2172e4-42fc-42fe-b1ad-9d6a974d4343.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 |
|---|
| 49884-948-52 | 49884094852 | 1 in 1 PACKET | | | | | | Historical |
| 49884-948-72 | 49884094872 | 30 PACKET in 1 CARTON (49884-948-72) / 1 POWDER, FOR SOLUTION in 1 PACKET (49884-948-52) | 30 packet | 2020-10-01 | 0000-00-00 | No | No | Current |