Omeprazole
- Product NDC
- 0378-6150
- 11-digit product format
- 003786150
- Labeler code
- 0378
- Product ID
- 0378-6150_54a04f22-d835-47c6-b249-252b68f9074a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA075876
- Marketing category
- ANDA
- Marketing start
- 2003-08-04
- Marketing end
- 2020-01-31
- 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
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
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 INGREDIENT | KG60484QX9 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| OMEPRAZOLE | ACTIVE MOIETY | KG60484QX9 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.] | 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 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.] | 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 [DISPENSING SOLUTIONS, INC.] | 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 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| METHACRYLIC ACID | INACTIVE INGREDIENT | 1CS02G8656 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| METHACRYLIC ACID | INACTIVE INGREDIENT | 1CS02G8656 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| OLEIC ACID | INACTIVE INGREDIENT | 2UMI9U37CP | OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| OLEIC ACID | INACTIVE INGREDIENT | 2UMI9U37CP | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.] | 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 [DISPENSING SOLUTIONS, INC.] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.] | 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 [DISPENSING SOLUTIONS, INC.] | 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 [DISPENSING SOLUTIONS, INC.] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | OMEPRAZOLE CAPSULE, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed RxNorm Mappings#