Lansoprazole
- Product NDC
- 82009-039
- 11-digit product format
- 820090039
- Labeler code
- 82009
- Product ID
- 82009-039_2f333840-e837-3207-e063-6294a90aea03
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA203083
- Marketing category
- ANDA
- Marketing start
- 2022-10-14
- Substance
- LANSOPRAZOLE
- Active strength
- 30 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 | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0K5C5T2QPG |
| Rxcui | 311277 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82009-039-05 | Lansoprazole | 500 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-039 | LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [QUALLENT PHARMACEUTICALS HEALTH LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250302_cc006372-32d3-4539-921a-6bc9ec496b28.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 |
|---|
| 82009-039-05 | 82009003905 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-039-05) | 2022-10-14 | 0000-00-00 | No | No | Current |