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NDC 75987-0010-03 DUEXIS 26.6; 800 mg/1; mg/1 Details
DUEXIS 26.6; 800 mg/1; mg/1
DUEXIS is a ORAL TABLET, COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Horizon Therapeutics USA, Inc.. The primary component is FAMOTIDINE; IBUPROFEN.
MedlinePlus Drug Summary
Prescription famotidine is used to treat ulcers (sores on the lining of the stomach or small intestine); gastroesophageal reflux disease (GERD, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus [tube that connects the mouth and stomach]); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome (tumors in the pancreas or small intestine that cause increased production of stomach acid). Over-the-counter famotidine is used to prevent and treat heartburn due to acid indigestion and sour stomach caused by eating or drinking certain foods or drinks. Famotidine is in a class of medications called H2 blockers. It works by decreasing the amount of acid made in the stomach.
Related Packages: 75987-0010-03Last Updated: 02/19/2023
MedLinePlus Full Drug Details: Famotidine
Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
Related Packages: 75987-0010-03Last Updated: 02/19/2023
MedLinePlus Full Drug Details: Ibuprofen
Product Information
| NDC | 75987-0010 |
|---|---|
| Product ID | 75987-010_3eae7ae8-f4f3-4cab-8f44-d48b524d3138 |
| Associated GPIs | 66109902320340 |
| GCN Sequence Number | 067901 |
| GCN Sequence Number Description | ibuprofen/famotidine TABLET 800-26.6MG ORAL |
| HIC3 | S2X |
| HIC3 Description | NSAID AND HISTAMINE H2 RECEPTOR ANTAGONIST COMB. |
| GCN | 30547 |
| HICL Sequence Number | 037986 |
| HICL Sequence Number Description | IBUPROFEN/FAMOTIDINE |
| Brand/Generic | Brand |
| Proprietary Name | DUEXIS |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ibuprofen and Famotidine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 26.6; 800 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | FAMOTIDINE; IBUPROFEN |
| Labeler Name | Horizon Therapeutics USA, Inc. |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022519 |
| Listing Certified Through | n/a |
Package
NDC 75987-0010-03 (75987001003)
| NDC Package Code | 75987-010-03 |
|---|---|
| Billing NDC | 75987001003 |
| Package | 90 TABLET, COATED in 1 BOTTLE (75987-010-03) |
| Marketing Start Date | 2011-12-05 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 26.5275 |
| Pricing Unit | EA |
| Effective Date | 2023-04-19 |
| NDC Description | DUEXIS 800-26.6 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |