Dexlansoprazole
- Product NDC
- 0378-2086
- 11-digit product format
- 003782086
- Labeler code
- 0378
- Product ID
- 0378-2086_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
- 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 SESQUIHYDRATE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HS2S9VK3NH |
| Rxcui | 833204, 833213 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-2086-05 | Dexlansoprazole | 500 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE PELLETS | 500 | | 2 |
| 0378-2086-77 | Dexlansoprazole | 90 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE PELLETS | 90 | | 2 |
| 0378-2086-93 | Dexlansoprazole | 30 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE PELLETS | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-2086 | DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.] | 2 | Current NDC, 3 package rows | 20240510_3f9699b5-7614-41cb-bd1d-ff02930e98f3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0378-2086-05 | 00378208605 | 500 in 1 BOTTLE, PLASTIC | | | | Historical |
| 0378-2086-77 | 00378208677 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2086-77) | 2024-01-22 | No | No | Current |
| 0378-2086-93 | 00378208693 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2086-93) | 2024-01-22 | No | No | Current |