Vimovo
- Product NDC
- 75987-030
- 11-digit product format
- 759870030
- Labeler code
- 75987
- Product ID
- 75987-030_3d7e5e03-f6bb-4b2a-b0ba-d0c3886ac81c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen and Esomeprazole Magnesium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Horizon Therapeutics USA, Inc.
- Application
- NDA022511
- Marketing category
- NDA
- Marketing start
- 2010-07-06
- Marketing end
- 0000-00-00
- Substance
- ESOMEPRAZOLE MAGNESIUM; NAPROXEN
- Active strength
- 20 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Esomeprazole Magnesium | ACTIVE INGREDIENT | R6DXU4WAY9 | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| Naproxen | ACTIVE INGREDIENT | 57Y76R9ATQ | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| Esomeprazole | ACTIVE MOIETY | N3PA6559FT | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| Naproxen | ACTIVE MOIETY | 57Y76R9ATQ | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| METHACRYLIC ACID | INACTIVE INGREDIENT | 1CS02G8656 | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON PHARMA INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75987-030 | VIMOVO (NAPROXEN AND ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [HORIZON THERAPEUTICS USA, INC.] | 17 | Legacy NDC | 20241207_baa47781-7151-4c75-a9a2-d2eac0a7d55e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 75987-030-04 | 75987003004 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (75987-030-04) | | 2010-07-06 | 0000-00-00 | No | No | Current |
| 75987-030-73 | 75987003073 | 1 BOTTLE in 1 CARTON (75987-030-73) > 6 TABLET, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2010-07-06 | 0000-00-00 | No | No | Current |