Omeprazole
- Product NDC
- 63874-553
- 11-digit product format
- 638740553
- Labeler code
- 63874
- Product ID
- 63874-553_094625fc-2d69-4268-8c79-7519eafe1051
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Altura Pharmaceuticals, Inc.
- Application
- ANDA075410
- Marketing category
- ANDA
- Marketing start
- 2010-01-01
- 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 |
|---|
| 63874-553-01 | Omeprazole | 100 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 100 | | 1 |
| 63874-553-30 | Omeprazole | 30 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 30 | | 1 |
| 63874-553-45 | Omeprazole | 45 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 45 | | 1 |
| 63874-553-60 | Omeprazole | 60 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 60 | | 1 |
| 63874-553-90 | Omeprazole | 90 in 1 BOTTLE, PLASTIC | 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 [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| OMEPRAZOLE | ACTIVE MOIETY | KG60484QX9 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| GLYCERYL BEHENATE | INACTIVE INGREDIENT | R8WTH25YS2 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ALTURA PHARMACEUTICALS, INC.] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ALTURA PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63874-553 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [ALTURA PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 5 package rows | 20100430_61b34d13-3b8b-4491-b5a3-e9740b2aaccb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 63874-553-01 | 63874055301 | 100 in 1 BOTTLE, PLASTIC | Historical |
| 63874-553-30 | 63874055330 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 63874-553-45 | 63874055345 | 45 in 1 BOTTLE, PLASTIC | Historical |
| 63874-553-60 | 63874055360 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 63874-553-90 | 63874055390 | 90 in 1 BOTTLE, PLASTIC | Historical |