Prescription drug · NDA
Ketalar (ketamine hydrochloride) NDC 0404-9880
Ketamine hydrochloride 10 mg/mL · Injection · Intramuscular, Intravenous · Henry Schein, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9880-20 | 00404988020 | 1 VIAL in 1 BAG (0404-9880-20) / 20 mL in 1 VIALMarketed from Jan 11, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Ketalar
- Generic name (nonproprietary)
- ketamine hydrochloride
- Active ingredients
- Ketamine hydrochloride — 10 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Henry Schein, Inc
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 016812
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0404-9880_66dc4477-9189-4ff8-b778-8ceb17a50802SPL ID 66dc4477-9189-4ff8-b778-8ceb17a50802SPL set ID 46dab560-8ecd-4d92-8c92-6baa2310b09bRxCUI 206967, 238082UNII 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
N400404988020followed by a unit qualifier and the quantityPackage 00404-9880-20. 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)
KETALAR (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. KETALAR 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 NDA 016812
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 |
|---|---|---|---|---|
| Ketalarketamine hydrochloride | Ketamine hydrochloride 100 mg/mL | InjectionIntramuscular, Intravenous | Par Health USA, LLC | 42023-115 |
| Ketalarketamine hydrochloride | Ketamine hydrochloride 10 mg/mL | InjectionIntramuscular, Intravenous | Par Health USA, LLC | 42023-113 |
| Ketalarketamine hydrochloride | Ketamine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Par Health USA, LLC | 42023-114 |