Omeprazole
- Product NDC
- 63868-471
- 11-digit product format
- 638680471
- Labeler code
- 63868
- Product ID
- 63868-471_bbbf9415-a533-1629-8f52-3f286fdc2d46
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Chain Drug Marketing Association INC
- Application
- ANDA207740
- Marketing category
- ANDA
- Marketing start
- 2020-02-01
- 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63868-471 | OMEPRAZOLE TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC] | 4 | Current NDC, Legacy NDC | 20241112_0057cb91-fc5e-8e9d-a926-299405c5c3a8.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 |
|---|
| 63868-471-14 | 63868047114 | 1 BOTTLE in 1 CARTON (63868-471-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2020-02-01 | 0000-00-00 | No | No | Current |
| 63868-471-42 | 63868047142 | 3 BOTTLE in 1 CARTON (63868-471-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2020-02-01 | 0000-00-00 | No | No | Current |