Omeprazole
- Product NDC
- 0615-8320
- 11-digit product format
- 006158320
- Labeler code
- 0615
- Product ID
- 0615-8320_251e926e-ecdc-4af3-8789-ec155b39959a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA075757
- Marketing category
- ANDA
- Marketing start
- 2019-07-01
- Marketing end
- 2022-12-31
- Substance
- OMEPRAZOLE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
|---|
| 0615-8320-05 | 00615832005 | 15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8320-05) | | 2019-10-03 | 2022-12-31 | No | No | Current |
| 0615-8320-14 | 00615832014 | 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8320-14) | | 2019-10-03 | 2022-12-31 | No | No | Current |
| 0615-8320-30 | 00615832030 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8320-30) > 5 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK | 6 blister pack | 2021-02-03 | 2022-12-31 | No | No | Current |
| 0615-8320-31 | 00615832031 | 31 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8320-31) | | 2019-10-03 | 2022-12-31 | No | No | Current |
| 0615-8320-39 | 00615832039 | 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8320-39) | | 2019-10-03 | 2022-12-31 | No | No | Current |