topcare lansoprazole
- Product NDC
- 36800-392
- 11-digit product format
- 368000392
- Labeler code
- 36800
- Product ID
- 36800-392_f5217e63-e0c1-4899-8bf0-e480d65e282f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Topco Associates LLC
- 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
- topcare 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 Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-392-01 | topcare lansoprazole | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | | 4 |
| 36800-392-01 | topcare lansoprazole | 1 in 1 CARTON | CAPSULE, DELAYED RELEASE | 1 | | 4 |
| 36800-392-03 | topcare lansoprazole | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | | 4 |
| 36800-392-03 | topcare lansoprazole | 3 in 1 CARTON | CAPSULE, DELAYED RELEASE | 3 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-392 | TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20250221_73aec019-5337-48a4-b95c-993fff9cfc2a.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 |
|---|
| 36800-392-01 | 36800039201 | 1 BOTTLE in 1 CARTON (36800-392-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2021-07-29 | 0000-00-00 | No | No | Current |
| 36800-392-03 | 36800039203 | 3 BOTTLE in 1 CARTON (36800-392-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2021-07-29 | 0000-00-00 | No | No | Current |