Omeprazole
- Product NDC
- 63874-553
- 11-digit product format
- 638740553
- Labeler code
- 63874
- Product ID
- 63874-553_094625fc-2d69-4268-8c79-7519eafe1051
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Altura Pharmaceuticals, Inc.
- Application
- ANDA075410
- Marketing category
- ANDA
- Marketing start
- 2010-01-01
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 63874-553-01 | Omeprazole | 100 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 100 | | 1 |
| 63874-553-30 | Omeprazole | 30 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 30 | | 1 |
| 63874-553-45 | Omeprazole | 45 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 45 | | 1 |
| 63874-553-60 | Omeprazole | 60 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 60 | | 1 |
| 63874-553-90 | Omeprazole | 90 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63874-553 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ALTURA PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 5 package rows | 20100430_61b34d13-3b8b-4491-b5a3-e9740b2aaccb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 63874-553-01 | 63874055301 | 100 in 1 BOTTLE, PLASTIC | Historical |
| 63874-553-30 | 63874055330 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 63874-553-45 | 63874055345 | 45 in 1 BOTTLE, PLASTIC | Historical |
| 63874-553-60 | 63874055360 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 63874-553-90 | 63874055390 | 90 in 1 BOTTLE, PLASTIC | Historical |