Lansoprazole
- Product NDC
- 0378-8015
- 11-digit product format
- 003788015
- Labeler code
- 0378
- Product ID
- 0378-8015_810def72-c1da-4c4d-9939-32b29be79e0c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA090763
- Marketing category
- ANDA
- Marketing start
- 2009-11-10
- 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 | 311277, 596843 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-8015-93 | Lansoprazole | 30 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE PELLETS | 30 | | 22 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-8015 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN PHARMACEUTICALS INC.] | 22 | Current NDC, Legacy NDC, 1 package rows | 20241004_c8fa7401-907f-41b6-a2e1-f4bc214f2cdf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-8015-93 | 00378801593 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-8015-93) | 2009-11-10 | 0000-00-00 | No | No | Current |