Omeprazole
- Product NDC
- 63548-7370
- 11-digit product format
- 635487370
- Labeler code
- 63548
- Product ID
- 63548-7370_74ebda17-011c-45bc-b22c-5182fc9f2ab8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- PLD Acquisitions LLC DBA Av�ma Pharma Solutions
- Application
- ANDA206582
- Marketing category
- ANDA
- Marketing start
- 2024-10-31
- Substance
- OMEPRAZOLE MAGNESIUM
- Active strength
- 20.6 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omeprazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEPRAZOLE MAGNESIUM | 20.6 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 426QFE7XLK |
| Rxcui | 402014 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63548-7370-2 | Omeprazole | 1 in 1 BOX | TABLET, DELAYED RELEASE | 1 | | 2 |
| 63548-7370-2 | Omeprazole | 42 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 42 | | 2 |
| 63548-7370-4 | Omeprazole | 14 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 14 | | 2 |
| 63548-7370-4 | Omeprazole | 1 in 1 BOX | TABLET, DELAYED RELEASE | 1 | | 2 |
| 63548-7370-8 | Omeprazole | 1 in 1 BOX | TABLET, DELAYED RELEASE | 1 | | 2 |
| 63548-7370-8 | Omeprazole | 28 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 28 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63548-7370 | OMEPRAZOLE TABLET, DELAYED RELEASE [PLD ACQUISITIONS LLC DBA AVÉMA PHARMA SOLUTIONS] | 2 | Current NDC, 6 package rows | 20241222_71add294-ff24-4bbf-9067-7c56ed7c9f1a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 63548-7370-2 | 63548737002 | 1 BOTTLE, PLASTIC in 1 BOX (63548-7370-2) / 42 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 2024-10-31 | No | No | Current |
| 63548-7370-4 | 63548737004 | 1 BOTTLE, PLASTIC in 1 BOX (63548-7370-4) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 2024-10-31 | No | No | Current |
| 63548-7370-8 | 63548737008 | 1 BOTTLE, PLASTIC in 1 BOX (63548-7370-8) / 28 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 2024-10-31 | No | No | Current |