Omeprazole
- Product NDC
- 16714-748
- 11-digit product format
- 167140748
- Labeler code
- 16714
- Product ID
- 16714-748_035e50ac-e188-4fe3-a3d0-dcfc172cfba7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA203270
- Marketing category
- ANDA
- Marketing start
- 2015-08-19
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16714-748-01 | 16714074801 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-748-01) | 2015-08-19 | 0000-00-00 | No | No | Current |
| 16714-748-02 | 16714074802 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-748-02) | 2015-08-19 | 0000-00-00 | No | No | Current |
| 16714-748-04 | 16714074804 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-748-04) | 2015-08-19 | 0000-00-00 | No | No | Current |