Prescription drug · NDA
Recarbrio NDC 0006-3856
imipenem anhydrous, cilastatin, and relebactam anhydrous · Imipenem anhydrous 500 mg/100mL + 2 more ingredients · Injection, Powder, For solution · Intravenous · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-3856-02 | 00006385602 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0006-3856-02) / 20 mL in 1 VIAL, SINGLE-DOSE (0006-3856-01)Marketed from Jan 6, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Recarbrio
- Generic name (nonproprietary)
- imipenem anhydrous, cilastatin, and relebactam anhydrous
- Active ingredients
- Imipenem anhydrous — 500 mg/100mLCilastatin — 500 mg/100mLRelebactam anhydrous — 250 mg/100mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- Merck Sharp & Dohme LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212819
- Marketing start
- Listing expires
- Other FDA classes
- Carbapenems (Chemical structure)Dipeptidase Inhibitors (Mechanism)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 0006-3856_11f74255-d000-4759-a561-136a5f13f667SPL ID 11f74255-d000-4759-a561-136a5f13f667SPL set ID be32f468-738b-40df-a425-591e12f65159RxCUI 2184142, 2184147UNII Q20IM7HE75, 141A6AMN38, 1OQF7TT3PF
- Pharmacologic class
- Penem Antibacterial; Renal Dehydropeptidase Inhibitor; beta Lactamase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400006385602followed by a unit qualifier and the quantityPackage 00006-3856-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
RECARBRIO is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor, indicated in adult and pediatric patients weighing at least 2 kg for the treatment of the following infections caused by susceptible gram-negative microorganisms: Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). ( 1.1 ) Complicated urinary tract infections, including pyelonephritis (cUTI) in patients who have limited or no alternative treatment options. ( 1.2 ) Complicated intra-abdominal infections (cIAI) in patients who have limited or no alternative treatment options. ( 1.3 ) Approval of t…
Excerpt only. Read the full label for complete information.