NDC codes

FDA NDC Directory
Product NDC (as listed)44567-400Labeler and product segments. Claims need a package NDC.
Product NDC at billing width44567-0400Add 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
44567-400-10445670400104456704001010 VIAL in 1 CARTON (44567-400-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (44567-400-01)Marketed from Jan 9, 2020

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/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 210773
Marketing start
Listing expires
Other FDA classes
Carbapenems (Chemical structure)
Identifiers
Product ID 44567-400_544f1665-f5bb-46bd-b6e8-efb61d6b152eSPL ID 544f1665-f5bb-46bd-b6e8-efb61d6b152e
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

N444567040010 followed by a unit qualifier and the quantity

Package 44567-0400-10. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 44567-400

What is NDC 44567-400?
44567-400 is the product NDC for Meropenem, Meropenem 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?
Meropenem.
What is the active ingredient?
Meropenem.
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 Meropenem?
42 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 43 Meropenem NDCs

Other NDCs under ANDA 210773

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

FDA NDC Directory listings under ANDA 210773
ProductStrengthForm · routeLabelerProduct NDC
MeropenemMeropenem 500 mg/10mLInjection, Powder, For solutionIntravenousHikma Pharmaceuticals USA Inc.0143-9485
MeropenemMeropenem 1 g/20mLInjection, Powder, For solutionIntravenousHikma Pharmaceuticals USA Inc.0143-9486
MeropenemMeropenem 500 mg/1Injection, Powder, For solutionIntravenousWG Critical Care, LLC44567-145
MeropenemMeropenem 1 g/1Injection, Powder, For solutionIntravenousWG Critical Care, LLC44567-146
MeropenemMeropenem 1 g/1Injection, Powder, For solutionIntravenousWG Critical Care, LLC44567-401

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