Omeprazole
- Product NDC
- 58517-020
- 11-digit product format
- 585170020
- Labeler code
- 58517
- Product ID
- 58517-020_f7e2081e-f97e-449a-a5e2-768ffcb931b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- New Horizon Rx Group, LLC
- Application
- ANDA076048
- Marketing category
- ANDA
- Marketing start
- 2013-12-31
- 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
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|
| 58517-020-30 | Omeprazole | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OMEPRAZOLE | ACTIVE INGREDIENT | KG60484QX9 | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| OMEPRAZOLE | ACTIVE MOIETY | KG60484QX9 | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| MAGNESIUM HYDROXIDE | INACTIVE INGREDIENT | NBZ3QY004S | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58517-020 | OMEPRAZOLE CAPSULE [NEW HORIZON RX GROUP, LLC] | 3 | Legacy NDC, 1 package rows | 20140101_3817cb8f-78f0-49cd-b55c-27f44a66d446.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 58517-020-30 | 58517002030 | 30 in 1 BOTTLE | Historical |