Omeprazole
- Product NDC
- 45865-342
- 11-digit product format
- 458650342
- Labeler code
- 45865
- Product ID
- 45865-342_4c9c1111-c13e-42fc-9c1d-5f9c54c86515
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA075576
- Marketing category
- ANDA
- Marketing start
- 2008-12-17
- 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 |
|---|
| 45865-342-15 | Omeprazole | 15 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 15 | | 1 |
| 45865-342-30 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 1 |
| 45865-342-42 | Omeprazole | 42 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 42 | | 1 |
| 45865-342-49 | Omeprazole | 100 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 100 | | 1 |
| 45865-342-60 | Omeprazole | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 1 |
| 45865-342-90 | Omeprazole | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OMEPRAZOLE | ACTIVE INGREDIENT | KG60484QX9 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| OMEPRAZOLE | ACTIVE MOIETY | KG60484QX9 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| MEGLUMINE | INACTIVE INGREDIENT | 6HG8UB2MUY | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| POLOXAMER 181 | INACTIVE INGREDIENT | 09Y8E6164A | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-342 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS] | 1 | Legacy NDC, 6 package rows | 20120710_2f381ecb-1e71-4f2f-acf0-d4918e0f3a1c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 45865-342-15 | 45865034215 | 15 in 1 BOTTLE | Historical |
| 45865-342-30 | 45865034230 | 30 in 1 BOTTLE | Historical |
| 45865-342-42 | 45865034242 | 42 in 1 BOTTLE | Historical |
| 45865-342-49 | 45865034249 | 100 in 1 BOTTLE | Historical |
| 45865-342-60 | 45865034260 | 60 in 1 BOTTLE | Historical |
| 45865-342-90 | 45865034290 | 90 in 1 BOTTLE | Historical |