Prescription drug · NDA
Ketalar (Ketamine hydrochloride) NDC 42023-113
Ketamine hydrochloride 10 mg/mL · Injection · Intramuscular, Intravenous · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42023-113-10 | 4202301131042023011310 | 10 VIAL in 1 CARTON (42023-113-10) / 20 mL in 1 VIALMarketed from Oct 1, 2007 |
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)
- Ketalar
- Generic name (nonproprietary)
- ketamine hydrochloride
- Active ingredients
- Ketamine hydrochloride — 10 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Par Health USA, LLCNDC labeler code 42023
- 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 42023-113_00836cdd-f898-4031-85f8-bb58a63b1a9bSPL ID 00836cdd-f898-4031-85f8-bb58a63b1a9bSPL set ID 14e8f864-8b8a-4e7e-8439-e510d3107063RxCUI 206967, 206970, 206972, 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
N442023011310followed by a unit qualifier and the quantityPackage 42023-0113-10. 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)
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.
About NDC 42023-113
- What is NDC 42023-113?
- 42023-113 is the product NDC for Ketalar (ketamine hydrochloride), Ketamine hydrochloride 10 mg/mL injection, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ketalar (Ketamine hydrochloride).
- What is the active ingredient?
- Ketamine hydrochloride.
- Who is the labeler?
- Par Health USA, LLC, NDC labeler code 42023. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ketalar?
- 3 other product NDCs are listed under this name. See all Ketalar NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ketalar products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ketalarketamine hydrochloride | Ketamine hydrochloride 10 mg/mL | InjectionIntramuscular, Intravenous | Henry Schein, Inc | 0404-9880 | 00404-9880-20 |
| Ketalarketamine hydrochloride | Ketamine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Par Health USA, LLC | 42023-114 | 42023-0114-10 |
| Ketalarketamine hydrochloride | Ketamine hydrochloride 100 mg/mL | InjectionIntramuscular, Intravenous | Par Health USA, LLC | 42023-115 | 42023-0115-10 |
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 10 mg/mL | InjectionIntramuscular, Intravenous | Henry Schein, Inc | 0404-9880 |
| Ketalarketamine hydrochloride | Ketamine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Par Health USA, LLC | 42023-114 |
| Ketalarketamine hydrochloride | Ketamine hydrochloride 100 mg/mL | InjectionIntramuscular, Intravenous | Par Health USA, LLC | 42023-115 |