NDC codes

FDA NDC Directory
Product NDC (as listed)44567-705Labeler and product segments. Claims need a package NDC.
Product NDC at billing width44567-0705Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
44567-705-104456707051010 VIAL in 1 CARTON (44567-705-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIALMarketed from Mar 9, 2021

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
Active ingredients
Imipenem anhydrous — 500 mg/1Cilastatin sodium — 500 mg/1
Dosage form
Injection, Powder, For solution
Route
Intravenous
Labeler
WG Critical Care, LLCNDC labeler code 44567
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207594
Marketing start
Listing expires
Other FDA classes
Carbapenems (Chemical structure)Dipeptidase Inhibitors (Mechanism)
Identifiers
Product ID 44567-705_6bfcc077-8c32-4c7e-abaa-f17eb2084231SPL ID 6bfcc077-8c32-4c7e-abaa-f17eb2084231SPL set ID 46f54df9-5afe-430c-aa19-0d84c2044b0bRxCUI 1726214UNII Q20IM7HE75, 5428WXZ74MUPC 0344567705016
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.

How CPT relates to drug billing

NDC on a medical claim

N444567070510 followed by a unit qualifier and the quantity

Package 44567-0705-10. 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 is not indicated in patients with meningitis because safety and eff…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 44567-705

What is NDC 44567-705?
44567-705 is the product NDC for Imipenem and Cilastatin, Imipenem anhydrous 500 mg/1; Cilastatin sodium 500 mg/1 injection, powder, for solution, listed with the FDA by WG Critical Care, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Imipenem and Cilastatin.
What is the active ingredient?
Imipenem anhydrous, Cilastatin sodium.
Who is the labeler?
WG Critical Care, LLC, NDC labeler code 44567. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Imipenem and Cilastatin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Imipenem and Cilastatinimipenem and cilastatin sodiumImipenem 500 mg/20mL; Cilastatin sodium 500 mg/20mLInjection, Powder, For solutionIntravenousFresenius Kabi USA, LLC63323-32263323-0322-25
Imipenem and Cilastatinimipenem and cilastatin sodiumImipenem 250 mg/20mL; Cilastatin sodium 250 mg/20mLInjection, Powder, For solutionIntravenousFresenius Kabi USA, LLC63323-34963323-0349-94

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