Lansoprazole
- Product NDC
- 71335-9680
- 11-digit product format
- 713359680
- Labeler code
- 71335
- Product ID
- 71335-9680_5dccd775-9b0f-4802-818f-d4914d3d82d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA203083
- Marketing category
- ANDA
- Marketing start
- 2020-05-18
- 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
openFDA Listing Details
- Product ID
- 71335-9680_5dccd775-9b0f-4802-818f-d4914d3d82d0
- SPL ID
- 5dccd775-9b0f-4802-818f-d4914d3d82d0
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Lansoprazole
- Generic name
- Lansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing start
- 2020-05-18
- Marketing category
- ANDA
- Application number
- ANDA203083
- Pharmacologic classes
- Inhibition Gastric Acid Secretion [PE]; Proton Pump Inhibitor [EPC]; Proton Pump Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| LANSOPRAZOLE | 15 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 0K5C5T2QPG |
| Rxcui | 596843 |
| Spl Set Id | 551ae468-1a2d-43d6-a2a8-4e5f26e0f982 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-9680-1 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9680-1) | 2023-04-06 | No |
| 71335-9680-2 | 15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9680-2) | 2023-04-06 | No |
| 71335-9680-3 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9680-3) | 2023-04-06 | No |
| 71335-9680-4 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9680-4) | 2023-04-06 | No |
| 71335-9680-5 | 28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9680-5) | 2023-04-06 | No |
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 |
|---|
| 71335-9680-1 | 71335968001 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9680-1) | 2023-04-06 | No | No | Historical |
| 71335-9680-2 | 71335968002 | 15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9680-2) | 2023-04-06 | No | No | Historical |
| 71335-9680-3 | 71335968003 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9680-3) | 2023-04-06 | No | No | Historical |
| 71335-9680-4 | 71335968004 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9680-4) | 2023-04-06 | No | No | Historical |
| 71335-9680-5 | 71335968005 | 28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9680-5) | 2023-04-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Lansoprazole | Bryant Ranch Prepack | 2023-04-06 | HUMAN PRESCRIPTION DRUG LABEL | 100 |