Prescription drug · NDA
Ativan (Lorazepam) NDC 0187-0063
Lorazepam .5 mg/1 · Tablet · Oral · Bausch Health US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-0063-01 | 00187006301 | 100 TABLET in 1 BOTTLE (0187-0063-01)Marketed from May 1, 2013 |
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)
- Ativan
- Generic name (nonproprietary)
- lorazepam
- Active ingredients
- Lorazepam — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bausch Health US LLCNDC labeler code 0187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017794
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 0187-0063_93bdf2de-1222-44a4-b4d5-2280f9ce58d8SPL ID 93bdf2de-1222-44a4-b4d5-2280f9ce58d8SPL set ID 89057c93-8155-4040-acec-64e877bd2b4cRxCUI 104719, 197900, 197901, 197902, 206821, 206828UNII 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 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
N400187006301followed by a unit qualifier and the quantityPackage 00187-0063-01. 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 Ativan (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 Ativan (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.
About NDC 0187-0063
- What is NDC 0187-0063?
- 0187-0063 is the product NDC for Ativan (lorazepam), Lorazepam .5 mg/1 tablet, listed with the FDA by Bausch Health US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ativan (Lorazepam).
- What is the active ingredient?
- Lorazepam.
- Who is the labeler?
- Bausch Health US LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ativan?
- 6 other product NDCs are listed under this name. See all Ativan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ativan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ativanlorazepam | Lorazepam 1 mg/1 | TabletOral | Bausch Health US LLC | 0187-0064 | 00187-0064-01 |
| Ativanlorazepam | Lorazepam 2 mg/1 | TabletOral | Bausch Health US LLC | 0187-0065 | 00187-0065-01 |
| Ativanlorazepam | Lorazepam 2 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6000 | 00641-6000-10 |
| Ativanlorazepam | Lorazepam 2 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6001 | 00641-6001-25 |
| Ativanlorazepam | Lorazepam 4 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6002 | 00641-6002-10 |
| Ativanlorazepam | Lorazepam 4 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6003 | 00641-6003-25 |
Other NDCs under NDA 017794
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 |
|---|---|---|---|---|
| Ativanlorazepam | Lorazepam 1 mg/1 | TabletOral | Bausch Health US LLC | 0187-0064 |
| Ativanlorazepam | Lorazepam 2 mg/1 | TabletOral | Bausch Health US LLC | 0187-0065 |