omeprazole
- Product NDC
- 41250-401
- 11-digit product format
- 412500401
- Labeler code
- 41250
- Product ID
- 41250-401_9215653a-ae65-423a-9eb6-c94f21fe4413
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Meijer Distribution Inc
- Application
- NDA022032
- Marketing category
- NDA
- Marketing start
- 2015-03-25
- Substance
- OMEPRAZOLE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- omeprazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEPRAZOLE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KG60484QX9 |
| Rxcui | 402014 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 41250-401-01 | omeprazole | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | | 8 |
| 41250-401-01 | omeprazole | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | | 8 |
| 41250-401-03 | omeprazole | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | | 8 |
| 41250-401-03 | omeprazole | 3 in 1 CARTON | TABLET, DELAYED RELEASE | 3 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OMEPRAZOLE | ACTIVE INGREDIENT | KG60484QX9 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 1 | |
| OMEPRAZOLE | ACTIVE MOIETY | KG60484QX9 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 1 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 1 | |
| MONOETHANOLAMINE | INACTIVE INGREDIENT | 5KV86114PT | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 1 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 1 | |
| SODIUM STEARATE | INACTIVE INGREDIENT | QU7E2XA9TG | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | OMEPRAZOLE CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 41250-401 | OMEPRAZOLE TABLET, DELAYED RELEASE [MEIJER DISTRIBUTION INC] | 8 | Current NDC, Legacy NDC, 4 package rows | 20250123_4e849a58-ad34-4d6e-a065-d1e5a1ac8218.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 41250-401-01 | 41250040101 | 1 BOTTLE in 1 CARTON (41250-401-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2020-02-03 | 0000-00-00 | No | No | Current |
| 41250-401-03 | 41250040103 | 3 BOTTLE in 1 CARTON (41250-401-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2015-03-25 | 0000-00-00 | No | No | Current |