lansoprazole
- Product NDC
- 71335-9695
- 11-digit product format
- 713359695
- Labeler code
- 71335
- Product ID
- 71335-9695_64b630b9-64f6-4bca-90c8-6c77ae81a49c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202319
- Marketing category
- ANDA
- Marketing start
- 2021-07-29
- 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 |
|---|
| LANSOPRAZOLE | 15 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 0K5C5T2QPG |
| Rxcui | 596843 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 0K5C5T2QPG | LANSOPRAZOLE | 103577-45-3 | LANSOPRAZOLE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-9695-1 | 71335969501 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9695-1) | 2023-03-29 | No | No | Current |
| 71335-9695-2 | 71335969502 | 15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9695-2) | 2024-04-03 | No | No | Current |
| 71335-9695-3 | 71335969503 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9695-3) | 2024-04-03 | No | No | Current |
| 71335-9695-4 | 71335969504 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9695-4) | 2024-04-03 | No | No | Current |
| 71335-9695-5 | 71335969505 | 28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9695-5) | 2024-04-03 | No | No | Current |