lansoprazole
- Product NDC
- 68382-543
- 11-digit product format
- 683820543
- Labeler code
- 68382
- Product ID
- 68382-543_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
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-543-06 | 68382054306 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68382-543-06) | | 2013-08-23 | 0000-00-00 | No | No | Current |
| 68382-543-10 | 68382054310 | 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68382-543-10) | | 2013-08-23 | 0000-00-00 | No | No | Current |
| 68382-543-77 | 68382054377 | 10 BLISTER PACK in 1 CARTON (68382-543-77) > 10 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK (68382-543-30) | 10 blister pack | 2013-08-23 | 0000-00-00 | No | No | Current |