Prescription drug · ANDA
Ketamine Hydrochloride NDC 55150-438
Ketamine hydrochloride 10 mg/mL · Injection · Intramuscular, Intravenous · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-438-10 | 55150043810 | 10 VIAL, MULTI-DOSE in 1 CARTON (55150-438-10) / 20 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 — 10 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Eugia US LLC
- 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 55150-438_35913e3d-e141-4596-bc4c-72deb8cbf932SPL ID 35913e3d-e141-4596-bc4c-72deb8cbf932SPL set ID f8b01c77-620d-4734-a771-b8524b65bccaRxCUI 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.
- NDC on a medical claim
N455150043810followed by a unit qualifier and the quantityPackage 55150-0438-10. 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 .
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 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.
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 50 mg/mL | InjectionIntramuscular, Intravenous | Eugia US LLC | 55150-439 |
| Ketamine Hydrochloride | Ketamine hydrochloride 100 mg/mL | InjectionIntramuscular, Intravenous | Eugia US LLC | 55150-440 |