Lansoprazole
- Product NDC
- 0378-6981
- 11-digit product format
- 003786981
- Labeler code
- 0378
- Product ID
- 0378-6981_00959575-41db-4810-b59c-1edd08568b17
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lansoprazole
- Dosage form
- TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA202396
- Marketing category
- ANDA
- Marketing start
- 2018-11-29
- Substance
- LANSOPRAZOLE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Inhibition Gastric Acid Secretion [PE], 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
- Lansoprazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LANSOPRAZOLE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0K5C5T2QPG |
| Rxcui | 351260, 351261 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-6981-32 | Lansoprazole | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING, D | 10 | | 5 |
| 0378-6981-85 | Lansoprazole | 5 in 1 CARTON | TABLET, ORALLY DISINTEGRATING, D | 5 | | 5 |
| 0378-6981-88 | Lansoprazole | 2 in 1 BOX | TABLET, ORALLY DISINTEGRATING, D | 2 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-6981 | LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20240330_20ff347c-ca18-497b-948d-1145035f2ffc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-6981-32 | 00378698132 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 0378-6981-85 | 00378698185 | 5 in 1 CARTON | | | | | | Historical |
| 0378-6981-88 | 00378698188 | 2 CARTON in 1 BOX (0378-6981-88) / 5 BLISTER PACK in 1 CARTON (0378-6981-85) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (0378-6981-32) | 2 carton | 2018-11-29 | 0000-00-00 | No | No | Current |