Lansoprazole
- Product NDC
- 43598-109
- 11-digit product format
- 435980109
- Labeler code
- 43598
- Product ID
- 43598-109_12c603b4-a2cf-bfae-92c1-8b87a30e12ad
- 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
- 2022-04-12
- 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 |
|---|
| 43598-109 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES INC.] | 7 | Current NDC, Legacy NDC | 20240727_4a701c0d-fef5-aa12-01e6-e3680a161a7d.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 |
|---|
| 43598-109-27 | 43598010927 | 2 BOTTLE in 1 CARTON (43598-109-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 2 bottle | 2022-04-12 | 0000-00-00 | No | No | Current |
| 43598-109-33 | 43598010933 | 3 BOTTLE in 1 CARTON (43598-109-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2022-04-12 | 0000-00-00 | No | No | Current |
| 43598-109-48 | 43598010948 | 12 POUCH in 1 CASE (43598-109-48) / 4000 CAPSULE, DELAYED RELEASE in 1 POUCH | 12 pouch | 01-FEB-24 | | | | Current |
| 43598-109-52 | 43598010952 | 1 BOTTLE in 1 CARTON (43598-109-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2022-04-12 | 0000-00-00 | No | No | Current |
| 43598-109-94 | 43598010994 | 4000 CAPSULE, DELAYED RELEASE in 1 POUCH (43598-109-94) | | 12-MAY-22 | | | | Current |