Prescription drug · ANDA
Lorazepam NDC 69315-905
Lorazepam 1 mg/1 · Tablet · Oral · Leading Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69315-905-01 | 69315090501 | 100 TABLET in 1 BOTTLE (69315-905-01)Marketed from May 16, 2023 | |
| 69315-905-05 | 69315090505 | 500 TABLET in 1 BOTTLE (69315-905-05)Marketed from May 16, 2023 | |
| 69315-905-10 | 69315090510 | 1000 TABLET in 1 BOTTLE (69315-905-10)Marketed from May 16, 2023 |
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)
- Lorazepam
- Generic name (nonproprietary)
- lorazepam
- Active ingredients
- Lorazepam — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Leading Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078203
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 69315-905_40249bb6-0d25-4b2f-aa4b-85c15af6bf8bSPL ID 40249bb6-0d25-4b2f-aa4b-85c15af6bf8bSPL set ID 5ca13415-4b77-4131-a9d2-6db26bc49167RxCUI 197900, 197901, 197902UNII O26FZP769LUPC 0369315905104, 0369315904053, 0369315904107, 0369315906101, 0369315906057, 0369315905050, 0369315904015, 0369315905012, 0369315906019
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469315090501followed by a unit qualifier and the quantityPackage 69315-0905-01. 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 Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078203
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 .5 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3096 |
| Lorazepam | Lorazepam 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0445 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0486 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0329 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-008 |
| Lorazepam | Lorazepam 2 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3010 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-647 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1467 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3227 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-122 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3242 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | DIRECT RX | 61919-062 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | Leading Pharma, LLC | 69315-904 |
| Lorazepam | Lorazepam 2 mg/1 | TabletOral | Leading Pharma, LLC | 69315-906 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-5508 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | PharmPak, Inc. | 54348-049 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-5509 |
| Lorazepam | Lorazepam 2 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-178 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2442 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-225 |
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