Prescription drug · ANDA

Meropenem NDC 63323-507

Meropenem 500 mg/10mL · Injection, Powder, For solution · Intravenous · Fresenius Kabi USA, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)63323-507Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63323-0507Add 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
63323-507-256332305072525 VIAL in 1 CARTON (63323-507-25) / 10 mL in 1 VIAL (63323-507-43)Marketed from Oct 14, 2011

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)
Meropenem
Generic name (nonproprietary)
meropenem
Active ingredients
Meropenem — 500 mg/10mL
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 091404
Marketing start
Listing expires
Other FDA classes
Carbapenems (Chemical structure)
Identifiers
Product ID 63323-507_8fe3d813-4656-49d6-ad91-6a075f3d3a82SPL ID 8fe3d813-4656-49d6-ad91-6a075f3d3a82SPL set ID 7a68d899-2678-43a9-a9c1-ef8f916b562fRxCUI 1722934, 1722939UNII FV9J3JU8B1
Pharmacologic class
Penem Antibacterial

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

N463323050725 followed by a unit qualifier and the quantity

Package 63323-0507-25. 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)

Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of: Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). ( 1.1 ) Complicated intra-abdominal infections (adult and pediatric patients). ( 1.2 ) Bacterial meningitis (pediatric patients 3 months of age and older only). ( 1.3 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for injection (I.V.) and other antibacterial drugs, Meropenem for injection (I.V.) should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 1.1 Complicated S…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-507

What is NDC 63323-507?
63323-507 is the product NDC for Meropenem, Meropenem 500 mg/10mL 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?
Meropenem.
What is the active ingredient?
Meropenem.
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 Meropenem?
46 other product NDCs are listed under this name. See all Meropenem 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 Meropenem NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MeropenemMeropenem 500 mg/10mLInjection, Powder, For solutionIntravenousHikma Pharmaceuticals USA Inc.0143-948500143-9485-10
MeropenemMeropenem 1 g/20mLInjection, Powder, For solutionIntravenousHikma Pharmaceuticals USA Inc.0143-948600143-9486-10
MeropenemMeropenem 500 mg/20mLInjection, Powder, For solutionIntravenousSagent Pharmaceuticals25021-16025021-0160-20
MeropenemMeropenem 1 g/30mLInjection, Powder, For solutionIntravenousSagent Pharmaceuticals25021-16125021-0161-30
MeropenemMeropenem 1 g/20mLInjectionIntravenousCivica, Inc.72572-41072572-0410-10
MeropenemMeropenem 500 mg/20mLInjectionIntravenousCivica, Inc.72572-41272572-0412-10
MeropenemMeropenem anhydrous 2 g/1InjectionIntravenousMylan Institutional LLC72078-08172078-0081-06
MeropenemMeropenem anhydrous 2 g/1InjectionIntravenousBROOKS STERISCIENCE LIMITED81962-00281962-0002-08
MeropenemMeropenem 500 mg/20mLInjectionIntravenousQilu Antibiotics Pharmaceutical Co., Ltd.51810-50251810-0502-02
MeropenemMeropenem 1 g/30mLInjectionIntravenousQilu Antibiotics Pharmaceutical Co., Ltd.51810-50351810-0503-02

All 47 Meropenem NDCs

Other NDCs under ANDA 091404

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 091404
ProductStrengthForm · routeLabelerProduct NDC
MeropenemMeropenem 1 g/20mLInjection, Powder, For solutionIntravenousFresenius Kabi USA, LLC63323-508
MeropenemMeropenem 1 g/20mLInjection, Powder, For solutionIntravenousHospira, Inc.0409-3412
MeropenemMeropenem 500 mg/10mLInjection, Powder, For solutionIntravenousHospira, Inc.0409-0222
MeropenemMeropenem 500 mg/10mLInjection, Powder, For solutionIntravenousHospira, Inc.0409-1390
MeropenemMeropenem 1 g/20mLInjection, Powder, For solutionIntravenousHospira, Inc.0409-1391
MeropenemMeropenem 1 g/20mLInjection, Powder, For solutionIntravenousFresenius Kabi USA, LLC63323-508
MeropenemMeropenem 1 g/20mLInjection, Powder, For solutionIntravenousFresenius Kabi USA, LLC63323-508

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