OMESEC
- Product NDC
- 16853-1308
- 11-digit product format
- 168531308
- Labeler code
- 16853
- Product ID
- 16853-1308_b16d55b9-70a2-4734-a8f4-bfd1cd108be4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Corporacion Infarmasa
- Application
- ANDA075410
- Marketing category
- ANDA
- Marketing start
- 2010-02-28
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE
- Active strength
- 20 mg/1
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16853-1308-1 | OMESEC | 14 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 14 | | 3 |
| 16853-1308-2 | OMESEC | 28 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 28 | | 3 |
| 16853-1308-3 | OMESEC | 42 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 42 | | 3 |
| 16853-1308-4 | OMESEC | 2 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 2 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OMEPRAZOLE | ACTIVE INGREDIENT | KG60484QX9 | OMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA] | 3 | |
| Omeprazole | ACTIVE MOIETY | KG60484QX9 | OMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA] | 3 | |
| DIETHYL PHTHALATE | INACTIVE INGREDIENT | UF064M00AF | OMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA] | 3 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | OMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA] | 3 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | OMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA] | 3 | |
| HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) | INACTIVE INGREDIENT | 8LDD2V82F5 | OMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA] | 3 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | OMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | OMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA] | 3 | |
| SODIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | 94255I6E2T | OMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA] | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | OMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16853-1308 | OMESEC (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [CORPORACION INFARMASA] | 3 | Legacy NDC, 4 package rows | 20100603_9217efc8-ec38-45e1-8319-32a6303cc050.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 16853-1308-1 | 16853130801 | 14 in 1 BLISTER PACK | Historical |
| 16853-1308-2 | 16853130802 | 28 in 1 BLISTER PACK | Historical |
| 16853-1308-3 | 16853130803 | 42 in 1 BLISTER PACK | Historical |
| 16853-1308-4 | 16853130804 | 2 in 1 BLISTER PACK | Historical |