topcare Lansoprazole
- Product NDC
- 36800-295
- 11-digit product format
- 368000295
- Labeler code
- 36800
- Product ID
- 36800-295_d6083bce-520b-4c14-bd0f-698e33b4b4f6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- lansoprazole
- Dosage form
- TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- NDA208025
- Marketing category
- NDA
- Marketing start
- 2020-06-18
- 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
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 | 351261 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-295-74 | topcare Lansoprazole | 14 in 1 CARTON | TABLET, ORALLY DISINTEGRATING, D | 14 | | 4 |
| 36800-295-74 | topcare Lansoprazole | 1 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING, D | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-295 | TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250228_ec5d6d5c-11e7-4932-a48f-fb72218ceccd.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 |
|---|
| 36800-295-74 | 36800029574 | 14 BLISTER PACK in 1 CARTON (36800-295-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | 14 blister pack | 2020-06-18 | 0000-00-00 | No | No | Current |