Prescription drug · ANDA
Imipenem and Cilastatin (Imipenem and cilastatin sodium) NDC 63323-349
Imipenem 250 mg/20mL; Cilastatin sodium 250 mg/20mL · Injection, Powder, For solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-349-94 | 63323034994 | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-349-94) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-349-41)Marketed from Jan 3, 2012 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Imipenem and Cilastatin
- Generic name (nonproprietary)
- imipenem and cilastatin sodium
- Active ingredients
- Imipenem — 250 mg/20mLCilastatin sodium — 250 mg/20mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090577
- Marketing start
- Listing expires
- Other FDA classes
- Carbapenems (Chemical structure)Dipeptidase Inhibitors (Mechanism)
- Identifiers
- Product ID 63323-349_fb64108d-9be7-4eef-9395-74c782e3a3c0SPL ID fb64108d-9be7-4eef-9395-74c782e3a3c0SPL set ID 0a1dd9b9-ada1-4bff-9dcb-18961254e9e8RxCUI 1726204UNII 5428WXZ74M, 71OTZ9ZE0AUPC 0363323349417, 0363323322410
- 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
N463323034994followed by a unit qualifier and the quantityPackage 63323-0349-94. 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)
Imipenem and Cilastatin for Injection, USP 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 : Imipenem and Cilastatin for Injection, USP (I.V.) is not indicated in patients with meningitis because safety and efficacy have…
Excerpt only. Read the full label for complete information.
About NDC 63323-349
- What is NDC 63323-349?
- 63323-349 is the product NDC for Imipenem and Cilastatin, Imipenem 250 mg/20mL; Cilastatin sodium 250 mg/20mL injection, powder, for solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Imipenem and Cilastatin (Imipenem and Cilastatin Sodium).
- What is the active ingredient?
- Imipenem, Cilastatin sodium.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Imipenem and Cilastatin?
- 2 other product NDCs are listed under this name. See all Imipenem and Cilastatin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Imipenem and Cilastatin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Imipenem and Cilastatin | Imipenem anhydrous 500 mg/1; Cilastatin sodium 500 mg/1 | Injection, Powder, For solutionIntravenous | WG Critical Care, LLC | 44567-705 | 44567-0705-10 |
| Imipenem and Cilastatinimipenem and cilastatin sodium | Imipenem 500 mg/20mL; Cilastatin sodium 500 mg/20mL | Injection, Powder, For solutionIntravenous | Fresenius Kabi USA, LLC | 63323-322 | 63323-0322-25 |
Other NDCs under ANDA 090577
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Imipenem and Cilastatinimipenem and cilastatin sodium | Imipenem 500 mg/20mL; Cilastatin sodium 500 mg/20mL | Injection, Powder, For solutionIntravenous | Fresenius Kabi USA, LLC | 63323-322 |