BERKLEY AND JENSEN LANSOPRAZOLE
- Product NDC
- 68391-823
- 11-digit product format
- 683910823
- Labeler code
- 68391
- Product ID
- 68391-823_0ad7d69d-29af-43c5-81a6-6f370591ef9f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- BJWC
- Application
- ANDA202319
- Marketing category
- ANDA
- Marketing start
- 2022-10-21
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BERKLEY AND JENSEN LANSOPRAZOLE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LANSOPRAZOLE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0K5C5T2QPG |
| Rxcui | 596843 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68391-823-00 | BERKLEY AND JENSEN LANSOPRAZOLE | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | | 2 |
| 68391-823-03 | BERKLEY AND JENSEN LANSOPRAZOLE | 3 in 1 PACKAGE | CAPSULE, DELAYED RELEASE | 3 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68391-823 | BERKLEY AND JENSEN LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BJWC] | 1 | Current NDC, 2 package rows | 20250216_b859e8dc-e42e-448d-89fa-2fc79d9cac32.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68391-823-00 | 68391082300 | 14 in 1 BOTTLE | | | | | Historical |
| 68391-823-03 | 68391082303 | 3 BOTTLE in 1 PACKAGE (68391-823-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68391-823-00) | 3 bottle | 2022-10-21 | No | No | Historical |