NDC 43598-096 – Javygtor
Sapropterin Dihydrochloride 100 mg/1 · Tablet · Oral
Product NDC43598-096
Product details
- Brand name
- Javygtor
- Generic name
- Sapropterin Dihydrochloride
- Labeler
- Dr. Reddys Laboratories Inc
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- ANDA · ANDA207685
- Marketed since
- October 3, 2022
- Listing expires
- December 31, 2026
- Pharmacologic class
- Phenylalanine Hydroxylase Activator
Active ingredients
- Sapropterin Dihydrochloride 100 mg/1
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 43598-096-04 | 120 TABLET in 1 BOTTLE (43598-096-04) | Oct 3, 2022 |
| 43598-096-05 | 500 TABLET in 1 BOTTLE (43598-096-05) | Oct 3, 2022 |
| 43598-096-30 | 30 TABLET in 1 BOTTLE (43598-096-30) | Oct 3, 2022 |
Recalls mentioning this NDC
- D-0117-2025 Dec 18, 2024 · Class III
Failed Impurities/Degradation Specifications