Nintedanib esylate
- Product NDC
- 33342-551
- Requested package NDC
- 33342-551-09
- 11-digit product format
- 333420551
- Labeler code
- 33342
- Product ID
- 33342-551_9925b305-c1fb-43b6-a5fd-e03f14f28e6c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nintedanib esylate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA219926
- Marketing category
- ANDA
- Marketing start
- 2026-08-03
- Substance
- NINTEDANIB ESYLATE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC]; Protein Kinase Inhibitors [MoA]
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nintedanib esylate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NINTEDANIB ESYLATE | 150 mg/1 |
Harmonized UNII identifiers#
UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table| Identifier | FDA.report destination |
|---|
| 42F62RTZ4G | Internal UNII lookup |
Harmonized SPL set identifiers#
SPL set identifiers page 1 of 1 · 1 matching rows.
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Status |
|---|
| 33342-551-09 | 33342055109 | 60 CAPSULE in 1 BOTTLE (33342-551-09) | 60 capsule | 2026-08-03 | 0 | Current |