Omeprazole
- Product NDC
- 53808-0746
- 11-digit product format
- 538080746
- Labeler code
- 53808
- Product ID
- 53808-0746_596008d9-a14e-42a8-b2f4-799480123e7b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA075876
- Marketing category
- ANDA
- Marketing start
- 2009-07-01
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- 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 |
|---|
| 53808-0746-1 | Omeprazole | 30 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OMEPRAZOLE | ACTIVE INGREDIENT | KG60484QX9 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| OMEPRAZOLE | ACTIVE MOIETY | KG60484QX9 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| DIBUTYL SEBACATE | INACTIVE INGREDIENT | 4W5IH7FLNY | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| ETHYLCELLULOSE | INACTIVE INGREDIENT | 7Z8S9VYZ4B | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| METHACRYLIC ACID | INACTIVE INGREDIENT | 1CS02G8656 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| OLEIC ACID | INACTIVE INGREDIENT | 2UMI9U37CP | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53808-0746 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20100611_1577bc9c-24d3-450e-b438-d4f1b5db6485.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53808-0746-1 | 53808074601 | 30 in 1 BLISTER PACK | Historical |