JAVYGTOR
- Product NDC
- 43598-096
- 11-digit product format
- 435980096
- Labeler code
- 43598
- Product ID
- 43598-096_ce2e0e3a-40e4-33ed-3cad-e166dd2245a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sapropterin Dihydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dr. Reddys Laboratories Inc
- Application
- ANDA207685
- Marketing category
- ANDA
- Marketing start
- 2022-10-03
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- JAVYGTOR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SAPROPTERIN DIHYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RG277LF5B3 |
| Rxcui | 1486687, 2612671 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-096-04 | JAVYGTOR | 120 in 1 BOTTLE | TABLET | 120 | | 2 |
| 43598-096-05 | JAVYGTOR | 500 in 1 BOTTLE | TABLET | 500 | | 2 |
| 43598-096-30 | JAVYGTOR | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-096 | JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE) TABLET [DR. REDDYS LABORATORIES INC] | 2 | Current NDC, Legacy NDC, 3 package rows | 20241123_d9f3723f-bf7d-9a72-2ef9-41c5508d6ab4.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 |
|---|
| 43598-096-04 | 43598009604 | 120 TABLET in 1 BOTTLE (43598-096-04) | 120 tablet | 2022-10-03 | 0000-00-00 | No | No | Current |
| 43598-096-05 | 43598009605 | 500 TABLET in 1 BOTTLE (43598-096-05) | 500 tablet | 2022-10-03 | 0000-00-00 | No | No | Current |
| 43598-096-30 | 43598009630 | 30 TABLET in 1 BOTTLE (43598-096-30) | 30 tablet | 2022-10-03 | 0000-00-00 | No | No | Current |