Omeprazole
- Product NDC
- 68382-411
- 11-digit product format
- 683820411
- Labeler code
- 68382
- Product ID
- 68382-411_d0074baa-52cb-4039-9bd8-966a36ff70da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA091352
- Marketing category
- ANDA
- Marketing start
- 2012-11-23
- Substance
- OMEPRAZOLE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KG60484QX9 |
| Rxcui | 198051, 199119, 200329 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-411-01 | Omeprazole | 100 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 100 | | 18 |
| 68382-411-05 | Omeprazole | 500 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 500 | | 18 |
| 68382-411-06 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 18 |
| 68382-411-10 | Omeprazole | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | | 18 |
| 68382-411-16 | Omeprazole | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OMEPRAZOLE | ACTIVE INGREDIENT | KG60484QX9 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| OMEPRAZOLE | ACTIVE MOIETY | KG60484QX9 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| ACETONE | INACTIVE INGREDIENT | 1364PS73AF | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) | INACTIVE INGREDIENT | 8LDD2V82F5 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| SODIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | 94255I6E2T | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-411 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS USA INC.] | 18 | Current NDC, Legacy NDC, 5 package rows | 20230513_9c22ceb2-2c34-43c3-9a35-2589c9078741.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-411-01 | 68382041101 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-01) | 2012-11-23 | 0000-00-00 | No | No | Current |
| 68382-411-05 | 68382041105 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-05) | 2012-11-23 | 0000-00-00 | No | No | Current |
| 68382-411-06 | 68382041106 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-06) | 2012-11-23 | 0000-00-00 | No | No | Current |
| 68382-411-10 | 68382041110 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-10) | 2012-11-23 | 0000-00-00 | No | No | Current |
| 68382-411-16 | 68382041116 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-411-16) | 2012-11-23 | 0000-00-00 | No | No | Current |