What is NDC 65219-650?

65219-650 is the product NDC for Midazolam In Sodium Chloride, Midazolam hydrochloride 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.

FRESENIUS KABI USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Midazolam In Sodium Chloride?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Midazolam In Sodium Chloride NDC 65219-650

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-650Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0650Add 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
65219-650-10	6521906501065219065010	10 POUCH in 1 CARTON (65219-650-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAGMarketed from Jan 15, 2025
65219-650-50	6521906505065219065050	10 POUCH in 1 CARTON (65219-650-50) / 1 BAG in 1 POUCH / 50 mL in 1 BAGMarketed from Jan 15, 2025

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): Midazolam In Sodium Chloride
Generic name (nonproprietary): midazolam in sodium chloride
Active ingredients: Midazolam hydrochloride — 1 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: FRESENIUS KABI USA, LLCNDC labeler code 65219
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218993
Marketing start: Jan 15, 2025
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 65219-650_a43f63a4-8a7f-4a1b-b9a0-4198486cfef6SPL ID a43f63a4-8a7f-4a1b-b9a0-4198486cfef6SPL set ID c8f51630-e776-4bc6-ba4d-b714e8c3b8f2RxCUI 2541170, 2541171UNII W7TTW573JJUPC 0365219650027, 0365219650058
Pharmacologic class: Benzodiazepine

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

N465219065010 followed by a unit qualifier and the quantity

Package 65219-0650-10. 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 Jan 31, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Midazolam in 0.9% Sodium Chloride Injection is indicated: • Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting. Midazolam in 0.9% Sodium Chloride Injection is a benzodiazepine indicated for: continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65219-650

What is NDC 65219-650?: 65219-650 is the product NDC for Midazolam In Sodium Chloride, Midazolam hydrochloride 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?: Midazolam In Sodium Chloride.
What is the active ingredient?: Midazolam hydrochloride.
Who is the labeler?: FRESENIUS KABI USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Midazolam In Sodium Chloride?: 7 other product NDCs are listed under this name. See all Midazolam In Sodium Chloride 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 Midazolam In Sodium Chloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Midazolam in Sodium Chloridemidazolam hydrochloride	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-688	25021-0688-8225021-0688-87
Midazolam In Sodium Chloride	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-618	68083-0618-10
Midazolam In Sodium Chloride	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-619	68083-0619-10
Midazolam in Sodium Chloride	Midazolam hydrochloride 1 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9379	00143-9379-10
Midazolam in Sodium Chloride	Midazolam hydrochloride 1 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9380	00143-9380-10
Midazolam in Sodium Chloridemidazolam	Midazolam 1 mg/mL	Injection, SolutionIntravenous	WG Critical Care, LLC.	44567-610	44567-0610-10
Midazolam in Sodium Chloridemidazolam	Midazolam 1 mg/mL	Injection, SolutionIntravenous	WG Critical Care, LLC.	44567-611	44567-0611-10

Other NDCs under ANDA 218993

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

FDA NDC Directory listings under ANDA 218993
Product	Strength	Form · route	Labeler	Product NDC
Midazolam in Sodium Chloridemidazolam hydrochloride	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-688
Midazolam In Sodium Chloride	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-618
Midazolam In Sodium Chloride	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-619