Prescription drug · NDA
Primaxin IV (Imipenem and cilastatin sodium) NDC 0006-3516
Imipenem 500 mg/100mL; Cilastatin sodium 500 mg/100mL · Injection, Powder, For solution · Intravenous · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-3516-59 | 00006351659 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0006-3516-59) / 100 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 26, 1985 |
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)
- Primaxin IVSuffix: IV
- Generic name (nonproprietary)
- imipenem and cilastatin sodium
- Active ingredients
- Imipenem — 500 mg/100mLCilastatin sodium — 500 mg/100mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- Merck Sharp & Dohme LLCNDC labeler code 0006
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050587
- Marketing start
- Listing expires
- Other FDA classes
- Carbapenems (Chemical structure)Dipeptidase Inhibitors (Mechanism)
- Identifiers
- Product ID 0006-3516_34854f9b-7be0-4bfb-8cd2-40baf206fb80SPL ID 34854f9b-7be0-4bfb-8cd2-40baf206fb80SPL set ID f41d8abd-7792-4918-1b93-bd83ea01955eRxCUI 1726204, 1726207, 1726214, 1726216UNII 71OTZ9ZE0A, 5428WXZ74MUPC 0300063516594
- Pharmacologic class
- Penem Antibacterial; Renal Dehydropeptidase 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
N400006351659followed by a unit qualifier and the quantityPackage 00006-3516-59. 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)
PRIMAXIN for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: Lower respiratory tract infections. ( 1.1 ) Urinary tract infections. ( 1.2 ) Intra-abdominal infections. ( 1.3 ) Gynecologic infections. ( 1.4 ) Bacterial septicemia. ( 1.5 ) Bone and joint infections. ( 1.6 ) Skin and skin structure infections. ( 1.7 ) Endocarditis. ( 1.8 ) Limitations of Use: PRIMAXIN is not indicated in patients with meningitis because safety and efficacy have not been established ( 1.9 ). PRIMAXIN is not recommended in pediatric pati…
Excerpt only. Read the full label for complete information.
About NDC 0006-3516
- What is NDC 0006-3516?
- 0006-3516 is the product NDC for Primaxin IV, Imipenem 500 mg/100mL; Cilastatin sodium 500 mg/100mL injection, powder, for solution, listed with the FDA by Merck Sharp & Dohme LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Primaxin IV (Imipenem and cilastatin sodium).
- What is the active ingredient?
- Imipenem, Cilastatin sodium.
- Who is the labeler?
- Merck Sharp & Dohme LLC, NDC labeler code 0006. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Primaxin IV?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.