What is NDC 63323-508?

63323-508 is the product NDC for Meropenem, Meropenem 1 g/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.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Meropenem NDC 63323-508 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-508Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0508Add 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 NDC	11-digit (billing)	Package	Copy
63323-508-31	63323050831	10 VIAL in 1 CARTON (63323-508-31) / 20 mL in 1 VIAL (63323-508-21)Marketed from Oct 26, 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 — 1 g/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 091404
Marketing start: Oct 26, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Carbapenems (Chemical structure)
Identifiers: Product ID 63323-508_6e7f961a-7766-4426-8aa4-096bfba99e56SPL ID 6e7f961a-7766-4426-8aa4-096bfba99e56SPL set ID 12714f80-d6e5-4453-b66c-62f57c16ddfcRxCUI 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

N463323050831 followed by a unit qualifier and the quantity

Package 63323-0508-31. 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 Mar 12, 2021.

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 63323-508

What is NDC 63323-508?: 63323-508 is the product NDC for Meropenem, Meropenem 1 g/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?: 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Meropenem	Meropenem 500 mg/10mL	Injection, Powder, For solutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9485	00143-9485-10
Meropenem	Meropenem 1 g/20mL	Injection, Powder, For solutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9486	00143-9486-10
Meropenem	Meropenem 500 mg/20mL	Injection, Powder, For solutionIntravenous	Sagent Pharmaceuticals	25021-160	25021-0160-20
Meropenem	Meropenem 1 g/30mL	Injection, Powder, For solutionIntravenous	Sagent Pharmaceuticals	25021-161	25021-0161-30
Meropenem	Meropenem 1 g/20mL	InjectionIntravenous	Civica, Inc.	72572-410	72572-0410-10
Meropenem	Meropenem 500 mg/20mL	InjectionIntravenous	Civica, Inc.	72572-412	72572-0412-10
Meropenem	Meropenem anhydrous 2 g/1	InjectionIntravenous	Mylan Institutional LLC	72078-081	72078-0081-06
Meropenem	Meropenem anhydrous 2 g/1	InjectionIntravenous	BROOKS STERISCIENCE LIMITED	81962-002	81962-0002-08
Meropenem	Meropenem 1 g/30mL	InjectionIntravenous	Qilu Antibiotics Pharmaceutical Co., Ltd.	51810-503	51810-0503-02
Meropenem	Meropenem 500 mg/20mL	InjectionIntravenous	Qilu Antibiotics Pharmaceutical Co., Ltd.	51810-502	51810-0502-02

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
Product	Strength	Form · route	Labeler	Product NDC
Meropenem	Meropenem 1 g/20mL	Injection, Powder, For solutionIntravenous	Hospira, Inc.	0409-3412
Meropenem	Meropenem 500 mg/10mL	Injection, Powder, For solutionIntravenous	Hospira, Inc.	0409-0222
Meropenem	Meropenem 500 mg/10mL	Injection, Powder, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-507
Meropenem	Meropenem 500 mg/10mL	Injection, Powder, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-507
Meropenem	Meropenem 500 mg/10mL	Injection, Powder, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-507
Meropenem	Meropenem 500 mg/10mL	Injection, Powder, For solutionIntravenous	Hospira, Inc.	0409-1390
Meropenem	Meropenem 1 g/20mL	Injection, Powder, For solutionIntravenous	Hospira, Inc.	0409-1391