What is NDC 65219-188?

65219-188 is the product NDC for ketamine hydrochloride, Ketamine hydrochloride 50 mg/mL injection, 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 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 ketamine hydrochloride?

22 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

ketamine hydrochloride NDC 65219-188

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-188Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0188Add 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
65219-188-10	6521901881065219018810	10 VIAL in 1 TRAY (65219-188-10) / 10 mL in 1 VIAL (65219-188-01)Marketed from Jul 10, 2023

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): ketamine hydrochloride
Generic name (nonproprietary): ketamine hydrochloride
Active ingredients: Ketamine hydrochloride — 50 mg/mL
Dosage form: Injection
Route: Intramuscular, Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 65219
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215808
Marketing start: Jul 10, 2023
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: General Anesthesia (Physiologic effect)
Identifiers: Product ID 65219-188_9acdebb0-6e88-42b2-ac45-da51aaad0f3cSPL ID 9acdebb0-6e88-42b2-ac45-da51aaad0f3cSPL set ID cc67b0fd-ca73-49f6-b5ca-705dc7331776RxCUI 238082, 238083, 238084UNII O18YUO0I83UPC 0365219186014, 0365219184010, 0365219188018
Pharmacologic class: General Anesthetic

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

N465219018810 followed by a unit qualifier and the quantity

Package 65219-0188-10. 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 Apr 23, 2025.

Indications (excerpt from the label)

Ketamine Hydrochloride Injection is indicated: as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. for the induction of anesthesia prior to the administration of other general anesthetic agents. as a supplement to other anesthetic agents. Ketamine Hydrochloride Injection is a general anesthetic indicated: as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation ( 1 ) for the induction of anesthesia prior to the administration of other general anesthetic agents ( 1 ) as a supplement to other anesthetic agents ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65219-188

What is NDC 65219-188?: 65219-188 is the product NDC for ketamine hydrochloride, Ketamine hydrochloride 50 mg/mL injection, 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?: ketamine hydrochloride.
What is the active ingredient?: Ketamine 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 ketamine hydrochloride?: 22 other product NDCs are listed under this name. See all ketamine hydrochloride 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 ketamine hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ketamine Hydrochloride	Ketamine hydrochloride 100 mg/mL	InjectionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9759	00404-9759-05
Ketamine Hydrochloride	Ketamine hydrochloride 10 mg/mL	InjectionIntramuscular, Intravenous	Baxter Healthcare Corporation	43066-117	43066-0117-05
Ketamine Hydrochloride	Ketamine hydrochloride 10 mg/mL	Injection, SolutionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-682	25021-0682-20
Ketamine Hydrochloride	Ketamine hydrochloride 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-683	25021-0683-10
Ketamine Hydrochloride	Ketamine hydrochloride 100 mg/mL	Injection, SolutionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-684	25021-0684-05
ketamine hydrochloride	Ketamine hydrochloride 10 mg/mL	InjectionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	65219-184	65219-0184-20
ketamine hydrochloride	Ketamine hydrochloride 100 mg/mL	InjectionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	65219-186	65219-0186-23
Ketamine Hydrochloride	Ketamine hydrochloride 10 mg/mL	Injection, SolutionIntramuscular, Intravenous	Gland Pharma Limited	68083-504	68083-0504-10
Ketamine Hydrochloride	Ketamine hydrochloride 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	Gland Pharma Limited	68083-505	68083-0505-10
Ketamine Hydrochloride	Ketamine hydrochloride 100 mg/mL	Injection, SolutionIntramuscular, Intravenous	Gland Pharma Limited	68083-506	68083-0506-10

All 23 ketamine hydrochloride NDCs

Other NDCs under ANDA 215808

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

FDA NDC Directory listings under ANDA 215808
Product	Strength	Form · route	Labeler	Product NDC
Ketamine Hydrochloride	Ketamine hydrochloride 100 mg/mL	InjectionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9759
ketamine hydrochloride	Ketamine hydrochloride 10 mg/mL	InjectionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	65219-184
ketamine hydrochloride	Ketamine hydrochloride 100 mg/mL	InjectionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	65219-186