Dexlansoprazole
- Product NDC
- 62332-823
- 11-digit product format
- 623320823
- Labeler code
- 62332
- Product ID
- 62332-823_c75e1427-f24f-46ab-8a19-29069bc6ca2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexlansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA219115
- Marketing category
- ANDA
- Marketing start
- 2025-11-14
- Substance
- DEXLANSOPRAZOLE
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dexlansoprazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXLANSOPRAZOLE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UYE4T5I70X |
| Rxcui | 833204, 833213 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62332-823-30 | Dexlansoprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 4 |
| 62332-823-90 | Dexlansoprazole | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62332-823-30 | 62332082330 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-823-30) | 2025-11-14 | No | No | Current |
| 62332-823-90 | 62332082390 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-823-90) | 2025-11-14 | No | No | Current |