Omeprazole
- Product NDC
- 63187-170
- 11-digit product format
- 631870170
- Labeler code
- 63187
- Product ID
- 63187-170_145db374-f2b5-40e4-8801-435b802c9b77
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA076048
- Marketing category
- ANDA
- Marketing start
- 2009-01-21
- Marketing end
- 2027-01-31
- Substance
- OMEPRAZOLE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omeprazole
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEPRAZOLE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KG60484QX9 |
| Rxcui | 200329 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-170-30 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 6 |
| 63187-170-60 | Omeprazole | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 6 |
| 63187-170-90 | Omeprazole | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Omeprazole | ACTIVE INGREDIENT | KG60484QX9 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
| Omeprazole | ACTIVE MOIETY | KG60484QX9 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
| MAGNESIUM HYDROXIDE | INACTIVE INGREDIENT | NBZ3QY004S | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-170 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP] | 6 | Current NDC, Legacy NDC, 3 package rows | 20241025_253451a6-02a9-4b27-aed7-f3dbc2e09682.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-170-30 | 63187017030 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-170-30) | 2019-01-01 | 2027-01-31 | No | No | Current |
| 63187-170-60 | 63187017060 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-170-60) | 2019-01-01 | 2027-01-31 | No | No | Current |
| 63187-170-90 | 63187017090 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-170-90) | 2019-01-01 | 2027-01-31 | No | No | Current |