NDC 16853-1308
OMESEC
Omeprazole
OMESEC is a Oral Capsule, Delayed Release in the Human Otc Drug category. It is labeled and distributed by Corporacion Infarmasa. The primary component is Omeprazole.
| Product ID | 16853-1308_b16d55b9-70a2-4734-a8f4-bfd1cd108be4 |
| NDC | 16853-1308 |
| Product Type | Human Otc Drug |
| Proprietary Name | OMESEC |
| Generic Name | Omeprazole |
| Dosage Form | Capsule, Delayed Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2010-02-28 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA075410 |
| Labeler Name | Corporacion Infarmasa |
| Substance Name | OMEPRAZOLE |
| Active Ingredient Strength | 20 mg/1 |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 16853-1308-4
2 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (16853-1308-4)
| Marketing Start Date | 2010-02-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 16853-1308-4 [16853130804]
OMESEC CAPSULE, DELAYED RELEASE
| Marketing Category | ANDA |
| Application Number | ANDA075410 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2010-02-28 |
| Inactivation Date | 2019-10-21 |
NDC 16853-1308-3 [16853130803]
OMESEC CAPSULE, DELAYED RELEASE
| Marketing Category | ANDA |
| Application Number | ANDA075410 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2010-02-28 |
| Inactivation Date | 2019-10-21 |
NDC 16853-1308-2 [16853130802]
OMESEC CAPSULE, DELAYED RELEASE
| Marketing Category | ANDA |
| Application Number | ANDA075410 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2010-02-28 |
| Inactivation Date | 2019-10-21 |
NDC 16853-1308-1 [16853130801]
OMESEC CAPSULE, DELAYED RELEASE
| Marketing Category | ANDA |
| Application Number | ANDA075410 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2010-02-28 |
| Inactivation Date | 2019-10-21 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| OMEPRAZOLE | 20 mg/1 |
OpenFDA Data
| SPL SET ID: | 9217efc8-ec38-45e1-8319-32a6303cc050 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "OMESEC" or generic name "Omeprazole"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 16853-1308 | OMESEC | OMESEC |
| 0363-1008 | Acid Reducer | Omeprazole |
| 0536-1322 | Acid Reducer | Omeprazole |
| 0113-7401 | Basic Care Omeprazole | Omeprazole |
| 0113-7520 | basic care omeprazole | omeprazole |
| 0113-7915 | Basic Care Omeprazole | Omeprazole |
| 0113-0520 | good sense omeprazole | omeprazole |
| 0113-0915 | Good Sense Omeprazole | Omeprazole |
| 0113-1723 | Good Sense Omeprazole | Omeprazole |
| 0113-1803 | good sense omeprazole delayed release | omeprazole |
| 0093-5294 | Omeprazole | Omeprazole |
| 0363-0007 | omeprazole | Omeprazole |
| 0363-0915 | omeprazole | Omeprazole |
| 0363-1607 | Omeprazole | Omeprazole |
| 0363-1819 | omeprazole | omeprazole |
| 0378-5211 | Omeprazole | omeprazole |
| 0378-5222 | Omeprazole | omeprazole |
| 0378-6150 | Omeprazole | omeprazole |
| 0615-1359 | Omeprazole | Omeprazole |
| 0615-2302 | Omeprazole | Omeprazole |
| 0615-2305 | Omeprazole | Omeprazole |
| 0615-7933 | Omeprazole | Omeprazole |
| 0615-8079 | Omeprazole | Omeprazole |
| 0615-8320 | Omeprazole | Omeprazole |
| 0615-8406 | Omeprazole | Omeprazole |
| 0781-2234 | Omeprazole | Omeprazole |
Trademark Results [OMESEC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMESEC 77745453 not registered Dead/Abandoned |
CORPORACION INFARMASA S.A. 2009-05-27 |
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