CALDOLOR® (IBUPROFEN) INJECTION CMS ISSUED J-CODE NOW ASSOCIATED WITH REIMBURSEMENT PRICE SUPPORTING NON-OPIOID PAIN MANAGEMENT
NASHVILLE, Tenn., Dec. 8, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX), today announced an important update regarding its Caldolor® (ibuprofen) Injection. The product's permanent J-code, J1741, is now officially associated with a reimbursement price, providing healthcare providers with a CMS-covered, non-opioid option for managing pain and fever.
As the nation continues to face an opioid crisis, non-opioid alternatives, like Caldolor, play a critical role in reducing reliance on opioid medications, supporting safer pain management strategies for patients. With the reimbursement price now linked to J1741, providers can access a CMS-covered, non-opioid pain management option and align treatment strategies with opioid-sparing initiatives.
Caldolor J-Code Details:
- Product: Caldolor® (ibuprofen) Injection
- J-Code: J1741 – Injection, ibuprofen, 100 mg
- Status: Now associated with reimbursement price
"With Caldolor now linked to an established reimbursement price, healthcare providers have a reimbursable non-opioid alternative to help address pain management," said Cumberland Pharmaceuticals CEO A.J. Kazimi. "This update supports providers in making clinically appropriate decisions while contributing to efforts to reduce opioid exposure and reinforces our commitment to improving access to Caldolor and ensuring patients receive the pain management they need."
Providers are encouraged to update their internal systems, billing teams, and reimbursement processes to reflect this change. For additional support with coding, coverage, or payment questions, please contact your Cumberland Pharmaceuticals representative or email caldolor@cumberlandpharma.com.
About Caldolor® (ibuprofen) Injection
Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. For full prescribing and safety information, including boxed warning, visit www.caldolor.com.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes:
- Acetadote® (acetylcysteine) injection, for the treatment of acetaminophen poisoning;
- Caldolor® (ibuprofen) injection, for the treatment of pain and fever;
- Kristalose® (lactulose) oral, a prescription laxative, for the treatment of constipation;
- Sancuso® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment;
- Vaprisol® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia;
- Vibativ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections, and
- Talicia®(omeprazole magnesium, amoxicillin and rifabutin) oral capsule, for the treatment of H. pylori infection.
The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis and Idiopathic Pulmonary Fibrosis.
For more information on Cumberland's approved products, including full prescribing information, please visit links to the individual product websites, which can be found on the company's website www.cumberlandpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's results of operations. These factors include market conditions, competition, an inability of manufacturers to produce Cumberland's products on a timely basis or failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, maintaining an effective sales and marketing infrastructure, natural disasters, public health epidemics, and other events beyond our control, as more fully discussed in the Company's most recent Form 10-K and subsequent 10-Qs as filed with the SEC. There can be no assurance that results anticipated by the Company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof.
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SOURCE Cumberland Pharmaceuticals Inc.