Omeprazole
- Product NDC
- 0904-5684
- 11-digit product format
- 009045684
- Labeler code
- 0904
- Product ID
- 0904-5684_71b6e1f9-5b2c-4540-b582-75dcc2793abd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA076048
- Marketing category
- ANDA
- Marketing start
- 2008-02-28
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- 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 |
|---|
| 0904-5684-61 | 00904568461 | 10 BLISTER PACK in 1 CARTON (0904-5684-61) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK | 10 blister pack | 2008-02-28 | 0000-00-00 | No | No | Current |