Omeprazole
- Product NDC
- 71335-1746
- 11-digit product format
- 713351746
- Labeler code
- 71335
- Product ID
- 71335-1746_2faac2fc-e15b-4bb5-98d8-c56675d7d9b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075410
- Marketing category
- ANDA
- Marketing start
- 2002-11-04
- 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 | 198051 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1746-0 | 71335174600 | 7 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1746-0) | 2022-02-14 | 0000-00-00 | No | No | Current |
| 71335-1746-1 | 71335174601 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1746-1) | 2021-01-11 | 0000-00-00 | No | No | Current |
| 71335-1746-2 | 71335174602 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1746-2) | 2021-01-11 | 0000-00-00 | No | No | Current |
| 71335-1746-3 | 71335174603 | 56 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1746-3) | 2021-04-19 | 0000-00-00 | No | No | Current |
| 71335-1746-4 | 71335174604 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1746-4) | 2021-04-02 | 0000-00-00 | No | No | Current |
| 71335-1746-5 | 71335174605 | 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1746-5) | 2021-05-03 | 0000-00-00 | No | No | Current |
| 71335-1746-6 | 71335174606 | 15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1746-6) | 2021-06-08 | 0000-00-00 | No | No | Current |
| 71335-1746-7 | 71335174607 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1746-7) | 2021-10-07 | 0000-00-00 | No | No | Current |
| 71335-1746-8 | 71335174608 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1746-8) | 2022-02-14 | 0000-00-00 | No | No | Current |
| 71335-1746-9 | 71335174609 | 28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1746-9) | 2022-02-14 | 0000-00-00 | No | No | Current |