Omeprazole Magnesium
- Product NDC
- 55315-367
- 11-digit product format
- 553150367
- Labeler code
- 55315
- Product ID
- 55315-367_b0461fd2-1ee8-0698-5fd2-d10a803f850e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- FREDS
- Application
- ANDA078878
- Marketing category
- ANDA
- Marketing start
- 2015-10-16
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE MAGNESIUM
- Active strength
- 20 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OMEPRAZOLE MAGNESIUM | ACTIVE INGREDIENT | 426QFE7XLK | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| omeprazole | ACTIVE MOIETY | KG60484QX9 | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| Gelatin | INACTIVE INGREDIENT | 2G86QN327L | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| HYPROMELLOSE 2208 (3 MPA.S) | INACTIVE INGREDIENT | 9H4L916OBU | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| Magnesium Oxide | INACTIVE INGREDIENT | 3A3U0GI71G | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A | INACTIVE INGREDIENT | NX76LV5T8J | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) | INACTIVE INGREDIENT | 5KY68S2577 | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| Polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| RAW SUGAR | INACTIVE INGREDIENT | 8M707QY5GH | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| Sodium Lauryl Sulfate | INACTIVE INGREDIENT | 368GB5141J | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55315-367 | OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [FREDS] | 3 | Legacy NDC | 20190202_1b1c6d51-b158-a408-1678-765a97f70f5e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55315-367-31 | 55315036731 | 1 BOTTLE in 1 CARTON (55315-367-31) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2015-10-16 | 0000-00-00 | No | No | Current |