Dexlansoprazole
- Product NDC
- 72162-2214
- 11-digit product format
- 721622214
- Labeler code
- 72162
- Product ID
- 72162-2214_f2ffd057-f79c-4337-9647-a9779b305b79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexlansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202294
- Marketing category
- ANDA
- Marketing start
- 2022-11-22
- Substance
- DEXLANSOPRAZOLE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| UYE4T5I70X | DEXLANSOPRAZOLE | 138530-94-6 | DEXLANSOPRAZOLE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-2214-3 | 72162221403 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72162-2214-3) | 2024-01-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Dexlansoprazole | Bryant Ranch Prepack | 2024-01-05 | HUMAN PRESCRIPTION DRUG LABEL | 100 |