Lansoprazole
- Product NDC
- 33342-310
- 11-digit product format
- 333420310
- Labeler code
- 33342
- Product ID
- 33342-310_75691c2d-2265-4153-bc3a-4f7d5d51e250
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA208671
- Marketing category
- ANDA
- Marketing start
- 2024-11-05
- 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 |
|---|
| 33342-310-07 | Lansoprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-310 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MACLEODS PHARMACEUTICALS LIMITED] | 1 | Current NDC, 1 package rows | 20241204_75691c2d-2265-4153-bc3a-4f7d5d51e250.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-310-07 | 33342031007 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-310-07) | 2024-11-05 | No | No | Current |