Dexlansoprazole
- Product NDC
- 49884-147
- 11-digit product format
- 498840147
- Labeler code
- 49884
- Product ID
- 49884-147_d173ea78-6398-49ea-8742-5d4093250cfd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexlansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Par Health USA, LLC
- Application
- ANDA202294
- Marketing category
- ANDA
- Marketing start
- 2023-06-10
- Substance
- DEXLANSOPRAZOLE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dexlansoprazole
- Listing expiration
- 2027-12-31
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 |
|---|
| 49884-147-11 | Dexlansoprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 25 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-147 | DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE [ENDO USA, INC.] | 24 | Current NDC, 1 package rows | 20240713_d7452a26-db20-42fc-868a-a3e3606ca895.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 49884-147-11 | 49884014711 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-147-11) | 2023-06-10 | No | No | Current |