Omeprazole
- Product NDC
- 43063-212
- 11-digit product format
- 430630212
- Labeler code
- 43063
- Product ID
- 43063-212_c8337074-d54b-112c-e053-2a95a90adfa5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA076048
- Marketing category
- ANDA
- Marketing start
- 2003-11-11
- 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
- 2022-12-31
- 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 |
|---|
| 43063-212-14 | 43063021214 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-212-14) | 2010-01-22 | 0000-00-00 | No | No | Current |
| 43063-212-30 | 43063021230 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-212-30) | 2010-01-22 | 0000-00-00 | No | No | Current |
| 43063-212-90 | 43063021290 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-212-90) | 2010-01-22 | 0000-00-00 | No | No | Current |
| 43063-212-93 | 43063021293 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-212-93) | 2010-01-22 | 0000-00-00 | No | No | Current |