NDC codes

FDA NDC Directory
Product NDC (as listed)63323-424Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63323-0424Add 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
63323-424-05633230424056332304240510 VIAL, MULTI-DOSE in 1 TRAY (63323-424-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-424-01)Marketed from Apr 5, 2005
63323-424-1063323042410633230424101 VIAL, MULTI-DOSE in 1 CARTON (63323-424-10) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Apr 5, 2005

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)
Flumazenil
Generic name (nonproprietary)
flumazenil
Active ingredients
Flumazenil — .1 mg/mL
Dosage form
Injection, 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 076955
Marketing start
Listing expires
Identifiers
Product ID 63323-424_9f9520ae-2135-4731-8fb2-8a0a771c302bSPL ID 9f9520ae-2135-4731-8fb2-8a0a771c302bSPL set ID a72d9fc1-121c-455d-93a9-002378c9968fRxCUI 204508UNII 40P7XK9392UPC 0363323424015, 0363323424107
Pharmacologic class
Benzodiazepine Antagonist

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

N463323042405 followed by a unit qualifier and the quantity

Package 63323-0424-05. 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)

INDICATIONS AND USAGE: Adult Patients Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose. Pediatric Patients (aged 1 to 17) Flumazenil Injection, USP is indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS , Pediatric Use ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-424

What is NDC 63323-424?
63323-424 is the product NDC for Flumazenil, Flumazenil .1 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Flumazenil.
What is the active ingredient?
Flumazenil.
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 Flumazenil?
20 other product NDCs are listed under this name. See all Flumazenil 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 Flumazenil NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
FlumazenilFlumazenil .1 mg/mLInjection, SolutionIntravenousHF Acquisition Co LLC, DBA HealthFirst51662-169951662-1699-03
FlumazenilFlumazenil .1 mg/mLInjection, SolutionIntravenousHenry Schein, Inc.0404-979300404-9793-05
FlumazenilFlumazenil .1 mg/mLInjection, SolutionIntravenousHenry Schein, Inc.0404-979400404-9794-10
FlumazenilFlumazenil .1 mg/mLInjection, SolutionIntravenousHF Acquisition Co LLC, DBA HealthFirst51662-157951662-1579-03
FlumazenilFlumazenil .1 mg/mLInjection, SolutionIntravenousHF Acquisition Co. LLC, DBA HealthFirst51662-125451662-1254-0151662-1254-03
FlumazenilFlumazenil .1 mg/mLInjection, SolutionIntravenousHF Acquisition Co. LLC, DBA Health First51662-125351662-1253-0151662-1253-03
FlumazenilFlumazenil .1 mg/mLInjectionIntravenousBaxter Healthcare Corporation36000-14836000-0148-10
FlumazenilFlumazenil .1 mg/mLInjectionIntravenousBaxter Healthcare Corporation36000-14936000-0149-10
FlumazenilFlumazenil .1 mg/mLInjectionIntravenousMedical Purchasing Solutions, LLC71872-720671872-7206-01
FlumazenilFlumazenil .1 mg/mLInjectionIntravenousMedical Purchasing Solutions, LLC71872-732171872-7321-01

All 21 Flumazenil NDCs

Other NDCs under ANDA 076955

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

FDA NDC Directory listings under ANDA 076955
ProductStrengthForm · routeLabelerProduct NDC
FlumazenilFlumazenil .1 mg/mLInjection, SolutionIntravenousHF Acquisition Co LLC, DBA HealthFirst51662-1579
FlumazenilFlumazenil .1 mg/mLInjection, SolutionIntravenousHF Acquisition Co LLC, DBA HealthFirst51662-1699
FlumazenilFlumazenil .1 mg/mLInjection, SolutionIntravenousMedical Purchasing Solutions, LLC71872-7375

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