Sapropterin Dihydrochloride
- Product NDC
- 43598-477
- 11-digit product format
- 435980477
- Labeler code
- 43598
- Product ID
- 43598-477_de177a71-0a19-b267-0676-34415c9d5fea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sapropterin Dihydrochloride
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Dr. Reddys Laboratories Inc
- Application
- ANDA209452
- Marketing category
- ANDA
- Marketing start
- 2021-04-01
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43598-477-30 | 43598047730 | 30 PACKET in 1 CARTON (43598-477-30) > 1 POWDER, FOR SOLUTION in 1 PACKET (43598-477-11) | 30 packet | 2021-04-01 | 0000-00-00 | No | No | Current |