Omeprazole
- Product NDC
- 50436-0065
- 11-digit product format
- 504360065
- Labeler code
- 50436
- Product ID
- 50436-0065_0385b658-c242-4bba-9d68-afdb4730b118
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Unit Dose Services
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50436-0065-1 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 5 |
| 50436-0065-2 | Omeprazole | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 5 |
| 50436-0065-3 | Omeprazole | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50436-0065 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 5 | Legacy NDC, 3 package rows | 20170702_ddef12fa-1585-4b0c-b148-da0c35e56515.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 50436-0065-1 | 50436006501 | 30 in 1 BOTTLE | Historical |
| 50436-0065-2 | 50436006502 | 60 in 1 BOTTLE | Historical |
| 50436-0065-3 | 50436006503 | 90 in 1 BOTTLE | Historical |