Prescription drug · ANDA
Ketamine Hydrochloride NDC 55150-439
Ketamine hydrochloride 50 mg/mL · Injection · Intramuscular, Intravenous · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-439-10 | 5515004391055150043910 | 10 VIAL, MULTI-DOSE in 1 CARTON (55150-439-10) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Mar 15, 2021 |
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
- Eugia US LLCNDC labeler code 55150
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076092
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 55150-439_a52dc360-8700-489c-b7c6-f5c278a6c1b7SPL ID a52dc360-8700-489c-b7c6-f5c278a6c1b7
- 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.
- NDC on a medical claim
N455150043910followed by a unit qualifier and the quantityPackage 55150-0439-10. 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 55150-439
- What is NDC 55150-439?
- 55150-439 is the product NDC for Ketamine Hydrochloride, Ketamine hydrochloride 50 mg/mL injection, listed with the FDA by Eugia US 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?
- Eugia US LLC, NDC labeler code 55150. 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.
Related NDCs: other Ketamine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 50 mg/mL | InjectionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 65219-188 | 65219-0188-10 |
| 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 |
Other NDCs under ANDA 076092
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ketamine Hydrochloride | Ketamine hydrochloride 10 mg/mL | InjectionIntramuscular, Intravenous | Eugia US LLC | 55150-438 |
| Ketamine Hydrochloride | Ketamine hydrochloride 100 mg/mL | InjectionIntramuscular, Intravenous | Eugia US LLC | 55150-440 |
| Ketamine Hydrochloride | Ketamine hydrochloride 100 mg/mL | InjectionIntramuscular, Intravenous | Eugia US LLC | 55150-526 |