lansoprazole
- Product NDC
- 68382-544
- 11-digit product format
- 683820544
- Labeler code
- 68382
- Product ID
- 68382-544_b828e447-56b6-4cab-bd49-053bcd4be948
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA202366
- Marketing category
- ANDA
- Marketing start
- 2013-08-23
- Marketing end
- 0000-00-00
- Substance
- LANSOPRAZOLE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LANSOPRAZOLE | ACTIVE INGREDIENT | 0K5C5T2QPG | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| LANSOPRAZOLE | ACTIVE MOIETY | 0K5C5T2QPG | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| HYDROXYPROPYL CELLULOSE (TYPE E) | INACTIVE INGREDIENT | 66O7AQV0RT | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| MAGNESIUM CARBONATE | INACTIVE INGREDIENT | 0E53J927NA | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| METHACRYLIC ACID | INACTIVE INGREDIENT | 1CS02G8656 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX] | 7 | |
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 |
|---|
| 68382-544-01 | 68382054401 | 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68382-544-01) | | 2013-08-23 | 0000-00-00 | No | No | Current |
| 68382-544-06 | 68382054406 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68382-544-06) | | 2013-08-23 | 0000-00-00 | No | No | Current |
| 68382-544-10 | 68382054410 | 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68382-544-10) | | 2013-08-23 | 0000-00-00 | No | No | Current |
| 68382-544-16 | 68382054416 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68382-544-16) | | 2013-08-23 | 0000-00-00 | No | No | Current |
| 68382-544-77 | 68382054477 | 10 BLISTER PACK in 1 CARTON (68382-544-77) > 10 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK (68382-544-30) | 10 blister pack | 2013-08-23 | 0000-00-00 | No | No | Current |