Dexlansoprazole
- Product NDC
- 0378-2085
- 11-digit product format
- 003782085
- Labeler code
- 0378
- Product ID
- 0378-2085_bd08545b-3f1d-44c5-bdd9-05acd7f69a0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dexlansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA205205
- Marketing category
- ANDA
- Marketing start
- 2024-01-22
- Substance
- DEXLANSOPRAZOLE SESQUIHYDRATE
- Active strength
- 30 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 |
|---|
| HS2S9VK3NH | DEXLANSOPRAZOLE SESQUIHYDRATE | 313640-86-7 | DEXLANSOPRAZOLE SESQUIHYDRATE |
| UYE4T5I70X | DEXLANSOPRAZOLE | 138530-94-6 | dexlansoprazole |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0378-2085-93 | 00378208593 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2085-93) | 2024-01-22 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Dexlansoprazole | Mylan Pharmaceuticals Inc. | 2023-07-15 | HUMAN PRESCRIPTION DRUG LABEL | 2 |