equaline omeprazole
- Product NDC
- 41163-634
- 11-digit product format
- 411630634
- Labeler code
- 41163
- Product ID
- 41163-634_d806739f-7f7b-42ae-af48-d1b0b22d3eef
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
- Route
- ORAL
- Labeler
- United Natural Foods, Inc. dba UNFI
- Application
- NDA209400
- Marketing category
- NDA
- Marketing start
- 2018-10-11
- Substance
- OMEPRAZOLE
- Active strength
- 20 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
- equaline omeprazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEPRAZOLE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KG60484QX9 |
| Rxcui | 2003656 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 41163-634-74 | equaline omeprazole | 14 in 1 CARTON | TABLET, ORALLY DISINTEGRATING, D | 14 | | 4 |
| 41163-634-74 | equaline omeprazole | 1 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING, D | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 41163-634 | EQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [UNITED NATURAL FOODS, INC. DBA UNFI] | 4 | Current NDC, Legacy NDC, 2 package rows | 20231004_78743f3b-257e-49df-98cd-6cc0e1b4e370.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 41163-634-74 | 41163063474 | 14 BLISTER PACK in 1 CARTON (41163-634-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | 14 blister pack | 2018-10-11 | 0000-00-00 | No | No | Current |