Lansoprazole
- Product NDC
- 76420-621
- 11-digit product format
- 764200621
- Labeler code
- 76420
- Product ID
- 76420-621_4dc7e065-4484-831d-e063-6294a90aaedc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA207394
- Marketing category
- ANDA
- Marketing start
- 2019-01-20
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lansoprazole
- Listing expiration
- 2027-12-31
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 |
|---|
| 76420-621-30 | Lansoprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 2 |
| 76420-621-60 | Lansoprazole | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 2 |
| 76420-621-90 | Lansoprazole | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-621 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [ASCLEMED USA, INC.] | 1 | Current NDC, 3 package rows | 20231006_71be1129-8562-476e-9d9b-99a21cbf52ec.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-621-30 | 76420062130 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-621-30) | 2026-03-24 | No | No | Current |
| 76420-621-60 | 76420062160 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-621-60) | 2026-03-24 | No | No | Current |
| 76420-621-90 | 76420062190 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-621-90) | 2023-10-05 | No | No | Current |