Lansoprazole
- Product NDC
- 43598-161
- 11-digit product format
- 435980161
- Labeler code
- 43598
- Product ID
- 43598-161_c91579b1-d6ec-c172-3e13-f4ac7805e56d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA202194
- Marketing category
- ANDA
- Marketing start
- 2022-10-01
- 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 | 596843 |
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-161 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES INC.] | 3 | Current NDC, Legacy NDC | 20241203_a24acc0b-7770-1087-77bd-048259a5bf72.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43598-161-33 | 43598016133 | 3 BOTTLE in 1 CARTON (43598-161-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2022-10-01 | 0000-00-00 | No | No | Current |
| 43598-161-52 | 43598016152 | 1 BOTTLE in 1 CARTON (43598-161-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2022-10-01 | 0000-00-00 | No | No | Current |