Topcare Lansoprazole
- Product NDC
- 36800-117
- 11-digit product format
- 368000117
- Labeler code
- 36800
- Product ID
- 36800-117_92a16930-8102-456e-99d4-a0aa10151c34
- 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
- 2012-09-10
- Marketing end
- 0000-00-00
- Substance
- LANSOPRAZOLE
- Active strength
- 15 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LANSOPRAZOLE | ACTIVE INGREDIENT | 0K5C5T2QPG | TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| LANSOPRAZOLE | ACTIVE MOIETY | 0K5C5T2QPG | TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| MEGLUMINE | INACTIVE INGREDIENT | 6HG8UB2MUY | TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-117 | TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 5 | Legacy NDC | 20200527_2f47db96-ac74-4171-aa80-9b2456515368.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 36800-117-01 | 36800011701 | 1 BOTTLE in 1 CARTON (36800-117-01) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2012-09-10 | 0000-00-00 | No | No | Current |
| 36800-117-02 | 36800011702 | 2 BOTTLE in 1 CARTON (36800-117-02) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 2 bottle | 2012-09-26 | 0000-00-00 | No | No | Current |
| 36800-117-03 | 36800011703 | 3 BOTTLE in 1 CARTON (36800-117-03) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2012-09-26 | 0000-00-00 | No | No | Current |