Omeprazole Magnesium
- Product NDC
- 37808-006
- 11-digit product format
- 378080006
- Labeler code
- 37808
- Product ID
- 37808-006_22f3dce6-c417-c720-8fb1-b45a46321c4a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- HEB
- Application
- ANDA078878
- Marketing category
- ANDA
- Marketing start
- 2016-01-01
- Substance
- OMEPRAZOLE MAGNESIUM
- 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 Magnesium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEPRAZOLE MAGNESIUM | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 426QFE7XLK |
| Rxcui | 198051 |
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OMEPRAZOLE MAGNESIUM | ACTIVE INGREDIENT | 426QFE7XLK | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| omeprazole | ACTIVE MOIETY | KG60484QX9 | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| CARRAGEENAN | INACTIVE INGREDIENT | 5C69YCD2YJ | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| HYPROMELLOSE 2208 (3 MPA.S) | INACTIVE INGREDIENT | 9H4L916OBU | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| MAGNESIUM OXIDE | INACTIVE INGREDIENT | 3A3U0GI71G | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) | INACTIVE INGREDIENT | 5KY68S2577 | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| POTASSIUM CHLORIDE | INACTIVE INGREDIENT | 660YQ98I10 | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| RAW SUGAR | INACTIVE INGREDIENT | 8M707QY5GH | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 37808-006 | OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [HEB] | 7 | Current NDC, Legacy NDC | 20240816_5d8b3f5f-f680-64ae-b360-c0bd06b2ac92.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 |
|---|
| 37808-006-33 | 37808000633 | 3 BOTTLE in 1 CARTON (37808-006-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2016-01-01 | 0000-00-00 | No | No | Current |
| 37808-006-52 | 37808000652 | 1 BOTTLE in 1 CARTON (37808-006-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2016-01-01 | 0000-00-00 | No | No | Current |