careone omeprazole
- Product NDC
- 41520-939
- 11-digit product format
- 415200939
- Labeler code
- 41520
- Product ID
- 41520-939_c40594a4-de5f-4267-bbe2-e07722d633e6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
- Route
- ORAL
- Labeler
- American Sales Company
- Application
- NDA209400
- Marketing category
- NDA
- Marketing start
- 2018-03-02
- 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
- careone 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 |
|---|
| 41520-939-55 | careone omeprazole | 14 in 1 CARTON | TABLET, ORALLY DISINTEGRATING, D | 14 | | 5 |
| 41520-939-55 | careone omeprazole | 3 in 1 CARTON | TABLET, ORALLY DISINTEGRATING, D | 3 | | 5 |
| 41520-939-74 | careone omeprazole | 14 in 1 CARTON | TABLET, ORALLY DISINTEGRATING, D | 14 | | 5 |
| 41520-939-74 | careone omeprazole | 1 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING, D | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 41520-939 | CAREONE OMEPRAZOLE (OMEPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [AMERICAN SALES COMPANY] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250406_5b88717a-e90c-4e74-ae2a-29270e14a3cc.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 |
|---|
| 41520-939-55 | 41520093955 | 3 CARTON in 1 CARTON (41520-939-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | 3 carton | 2018-03-06 | 0000-00-00 | No | No | Current |
| 41520-939-74 | 41520093974 | 14 BLISTER PACK in 1 CARTON (41520-939-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | 14 blister pack | 2018-03-02 | 0000-00-00 | No | No | Current |