Omeprazole
- Product NDC
- 43598-841
- 11-digit product format
- 435980841
- Labeler code
- 43598
- Product ID
- 43598-841_bf20de45-af46-d037-efd5-6efe069d0569
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Dr. Reddys Laboratories Inc
- Application
- ANDA207740
- Marketing category
- ANDA
- Marketing start
- 2020-10-01
- 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
- 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 | 402014 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-841-42 | Omeprazole | 3 in 1 CARTON | TABLET, DELAYED RELEASE | 3 | | 4 |
| 43598-841-42 | Omeprazole | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | | 4 |
| 43598-841-52 | Omeprazole | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | | 4 |
| 43598-841-52 | Omeprazole | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-841 | OMEPRAZOLE TABLET, DELAYED RELEASE [DR. REDDYS LABORATORIES INC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20241112_b377cb0b-14b2-04bb-f276-fd69a257f9ca.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 |
|---|
| 43598-841-42 | 43598084142 | 3 BOTTLE in 1 CARTON (43598-841-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2020-10-01 | 0000-00-00 | No | No | Current |
| 43598-841-52 | 43598084152 | 1 BOTTLE in 1 CARTON (43598-841-52) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2020-10-01 | 0000-00-00 | No | No | Current |