Prescription drug · NDA
Lorazepam NDC 0641-6048
Lorazepam 2 mg/mL · Injection · Intramuscular, Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6048-25 | 00641604825 | 25 VIAL in 1 CARTON (0641-6048-25) / 1 mL in 1 VIAL (0641-6048-01)Marketed from Jul 25, 1980 |
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)
- Lorazepam
- Generic name (nonproprietary)
- lorazepam
- Active ingredients
- Lorazepam — 2 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018140
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 0641-6048_329ddfc8-cf47-4584-a101-4727751e1005SPL ID 329ddfc8-cf47-4584-a101-4727751e1005SPL set ID 4084fa74-9fd2-45ef-9d56-27bfa31d4e46RxCUI 238100, 238101, 1665188, 1665326UNII O26FZP769L
- Pharmacologic class
- Benzodiazepine
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
N400641604825followed by a unit qualifier and the quantityPackage 00641-6048-25. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Status Epilepticus Lorazepam Injection is indicated for the treatment of status epilepticus. Preanesthetic Lorazepam Injection is indicated in adult patients for preanesthetic medication, producing sedation (sleepiness or drowsiness), relief of anxiety, and a decreased ability to recall events related to the day of surgery. It is most useful in those patients who are anxious about their surgical procedure and who would prefer to have diminished recall of the events of the day of surgery (see PRECAUTIONS, Information for Patients ).
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 018140
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 |
|---|---|---|---|---|
| Lorazepam | Lorazepam 2 mg/mL | InjectionIntramuscular, Intravenous | Civica, Inc. | 72572-380 |
| Ativanlorazepam | Lorazepam 2 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6000 |
| Lorazepam | Lorazepam 2 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6044 |
| Ativanlorazepam | Lorazepam 2 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6001 |
| Lorazepam | Lorazepam 4 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6045 |
| Lorazepam | Lorazepam 2 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6207 |
| Ativanlorazepam | Lorazepam 4 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6002 |
| Ativanlorazepam | Lorazepam 4 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6003 |
| Lorazepam | Lorazepam 2 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6046 |
| Lorazepam | Lorazepam 4 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6047 |
| Lorazepam | Lorazepam 4 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6049 |
| Lorazepam | Lorazepam 2 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6050 |
| Lorazepam | Lorazepam 4 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6051 |