Dexlansoprazole
- Product NDC
- 46708-824
- 11-digit product format
- 467080824
- Labeler code
- 46708
- Product ID
- 46708-824_24c33ba6-bf47-434e-903e-f7ced98e030e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexlansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA219115
- Marketing category
- ANDA
- Marketing start
- 2025-11-14
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dexlansoprazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXLANSOPRAZOLE | 60 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 |
|---|
| 46708-824-30 | Dexlansoprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 1 |
| 46708-824-90 | Dexlansoprazole | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-824-30 | 46708082430 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-824-30) | 2025-11-14 | No | No | Current |
| 46708-824-90 | 46708082490 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-824-90) | 2025-11-14 | No | No | Current |