Prescription drug · ANDA
Ketamine Hydrochloride NDC 0143-9509
Ketamine hydrochloride 100 mg/mL · Injection · Intramuscular, Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9509-10 | 0014395091000143950910 | 10 VIAL in 1 BOX (0143-9509-10) / 5 mL in 1 VIAL (0143-9509-01)Marketed from Jul 1, 1996 |
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)
- Ketamine Hydrochloride
- Generic name (nonproprietary)
- ketamine hydrochloride
- Active ingredients
- Ketamine hydrochloride — 100 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074524
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0143-9509_6ada9356-0968-46df-b067-d95509650c48SPL ID 6ada9356-0968-46df-b067-d95509650c48SPL set ID 58487c78-a641-4278-acc0-343596ee8683RxCUI 238083, 238084UNII O18YUO0I83UPC 0301439508106, 0301439509103
- 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
N400143950910followed by a unit qualifier and the quantityPackage 00143-9509-10. 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 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.
About NDC 0143-9509
- What is NDC 0143-9509?
- 0143-9509 is the product NDC for Ketamine Hydrochloride, Ketamine hydrochloride 100 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. 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?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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 074524
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 | Hikma Pharmaceuticals USA Inc. | 0143-9508 |
| Ketamine Hydrochloride | Ketamine hydrochloride 100 mg/mL | InjectionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7258 |
| Ketamine Hydrochloride | Ketamine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Civica, Inc. | 72572-320 |
| Ketamine Hydrochloride | Ketamine hydrochloride 100 mg/mL | InjectionIntramuscular, Intravenous | Civica, Inc. | 72572-321 |