Lansoprazole
- Product NDC
- 0536-1368
- 11-digit product format
- 005361368
- Labeler code
- 0536
- Product ID
- 0536-1368_ef21368f-e4df-c863-8e40-767c21fcf81b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Rugby Laboratories, Inc
- Application
- ANDA202194
- Marketing category
- ANDA
- Marketing start
- 2022-10-26
- 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 |
|---|
| 0536-1368 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [RUGBY LABORATORIES, INC] | 3 | Current NDC, Legacy NDC | 20241203_aa95216c-8985-d160-1743-ba168a35177f.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 |
|---|
| 0536-1368-13 | 00536136813 | 3 BOTTLE in 1 CARTON (0536-1368-13) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2022-10-26 | 0000-00-00 | No | No | Current |
| 0536-1368-88 | 00536136888 | 1 BOTTLE in 1 CARTON (0536-1368-88) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2022-10-26 | 0000-00-00 | No | No | Current |