Omeprazole Delayed-Release
- Product NDC
- 63304-445
- 11-digit product format
- 633040445
- Labeler code
- 63304
- Product ID
- 63304-445_b43f6b44-9de3-4efb-a467-487aee28f6a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Ranbaxy Laboratories Inc.
- Application
- NDA019810
- Marketing category
- NDA
- Marketing start
- 2008-07-25
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE
- Active strength
- 40 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 |
|---|
| 63304-445-01 | Omeprazole Delayed-Release | 100 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 100 | | 2 |
| 63304-445-10 | Omeprazole Delayed-Release | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | | 2 |
| 63304-445-30 | Omeprazole Delayed-Release | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OMEPRAZOLE | ACTIVE INGREDIENT | KG60484QX9 | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | |
| OMEPRAZOLE | ACTIVE MOIETY | KG60484QX9 | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | |
| FERRIC OXIDE | INACTIVE INGREDIENT | 1K09F3G675 | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-445 | OMEPRAZOLE DELAYED-RELEASE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [RANBAXY LABORATORIES INC.] | 2 | Legacy NDC, 3 package rows | 20090826_b43f6b44-9de3-4efb-a467-487aee28f6a0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 63304-445-01 | 63304044501 | 100 in 1 BOTTLE | Historical |
| 63304-445-10 | 63304044510 | 1000 in 1 BOTTLE | Historical |
| 63304-445-30 | 63304044530 | 30 in 1 BOTTLE | Historical |