DUEXIS
- Product NDC
- 75987-010
- 11-digit product format
- 759870010
- Labeler code
- 75987
- Product ID
- 75987-010_aa2ae91d-7664-4b8a-a700-a47a15459265
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen and Famotidine
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Horizon Therapeutics USA, Inc.
- Application
- NDA022519
- Marketing category
- NDA
- Marketing start
- 2011-12-05
- Marketing end
- 0000-00-00
- Substance
- FAMOTIDINE; IBUPROFEN
- Active strength
- 27 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Famotidine | ACTIVE INGREDIENT | 5QZO15J2Z8 | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| Ibuprofen | ACTIVE INGREDIENT | WK2XYI10QM | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| Famotidine | ACTIVE MOIETY | 5QZO15J2Z8 | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| Ibuprofen | ACTIVE MOIETY | WK2XYI10QM | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| FD&C BLUE No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| FD&C BLUE No. 2 | INACTIVE INGREDIENT | L06K8R7DQK | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON PHARMA INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75987-010 | DUEXIS (IBUPROFEN AND FAMOTIDINE) TABLET, COATED [HORIZON THERAPEUTICS USA, INC.] | 21 | Legacy NDC | 20241207_558b9f26-37b2-423b-932d-25a37afe57ec.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 75987-010-03 | 75987001003 | 90 TABLET, COATED in 1 BOTTLE (75987-010-03) | | 2011-12-05 | 0000-00-00 | No | No | Current |
| 75987-010-72 | 75987001072 | 9 BLISTER PACK in 1 CARTON (75987-010-72) > 3 TABLET, COATED in 1 BLISTER PACK | 9 blister pack | 2011-12-05 | 0000-00-00 | No | No | Current |