Ketamine Hydrochloride NDC 25021-683

NDC codes

FDA NDC Directory

Product NDC (as listed)25021-683Labeler and product segments. Claims need a package NDC.

Product NDC at billing width25021-0683Add 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
25021-683-10	25021068310	10 VIAL in 1 CARTON (25021-683-10) / 10 mL in 1 VIALMarketed from Jul 15, 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, Solution
Route: Intramuscular, Intravenous
Labeler: Sagent Pharmaceuticals
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216809
Marketing start: Jul 15, 2023
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: General Anesthesia (Physiologic effect)
Identifiers: Product ID 25021-683_51a16c65-47e0-405c-8c84-82a6a28b3efdSPL ID 51a16c65-47e0-405c-8c84-82a6a28b3efdSPL set ID 902c3785-a3cb-472b-ac15-394ac646271dRxCUI 238082, 238083, 238084UNII O18YUO0I83
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

N425021068310 followed by a unit qualifier and the quantity

Package 25021-0683-10. 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 May 1, 2023.

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)

Other NDCs under ANDA 216809

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

FDA NDC Directory listings under ANDA 216809
Product	Strength	Form · route	Labeler	Product NDC
Ketamine Hydrochloride	Ketamine hydrochloride 10 mg/mL	Injection, SolutionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-682
Ketamine Hydrochloride	Ketamine hydrochloride 100 mg/mL	Injection, SolutionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-684
Ketamine Hydrochloride	Ketamine hydrochloride 10 mg/mL	Injection, SolutionIntramuscular, Intravenous	Gland Pharma Limited	68083-504
Ketamine Hydrochloride	Ketamine hydrochloride 50 mg/mL	Injection, SolutionIntramuscular, Intravenous	Gland Pharma Limited	68083-505
Ketamine Hydrochloride	Ketamine hydrochloride 100 mg/mL	Injection, SolutionIntramuscular, Intravenous	Gland Pharma Limited	68083-506