Omeprazole
- Product NDC
- 50436-3125
- 11-digit product format
- 504363125
- Labeler code
- 50436
- Product ID
- 50436-3125_04c1739e-c969-4866-90a1-ee7284cb5ef6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA075410
- Marketing category
- ANDA
- Marketing start
- 2002-11-04
- 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
- 2020-12-31
- 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 |
|---|
| 50436-3125-1 | Omeprazole | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 6 |
| 50436-3125-2 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 6 |
| 50436-3125-3 | 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 [UNIT DOSE SERVICES] | 4 | |
| OMEPRAZOLE | ACTIVE MOIETY | KG60484QX9 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| ALUMINUM CHLOROHYDREX PROPYLENE GLYCOL | INACTIVE INGREDIENT | PGG6VG42HP | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| GLYCERYL BEHENATE | INACTIVE INGREDIENT | R8WTH25YS2 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50436-3125 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES] | 6 | Legacy NDC, 3 package rows | 20170729_c22dfa61-ca2e-419c-9ff6-484023793699.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 50436-3125-1 | 50436312501 | 60 in 1 BOTTLE | Historical |
| 50436-3125-2 | 50436312502 | 30 in 1 BOTTLE | Historical |
| 50436-3125-3 | 50436312503 | 90 in 1 BOTTLE | Historical |