Prescription drug · ANDA
Lorazepam NDC 0093-3425
Lorazepam .5 mg/1 · Tablet · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-3425-01 | 00093342501 | 100 TABLET in 1 BOTTLE, PLASTIC (0093-3425-01)Marketed from Dec 28, 2021 | |
| 0093-3425-05 | 00093342505 | 500 TABLET in 1 BOTTLE, PLASTIC (0093-3425-05)Marketed from Nov 5, 2021 | |
| 0093-3425-10 | 00093342510 | 1000 TABLET in 1 BOTTLE, PLASTIC (0093-3425-10)Marketed from Oct 11, 2021 |
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 — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072926
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 0093-3425_979c1de1-fca5-4909-9abf-a568e2a8a3deSPL ID 979c1de1-fca5-4909-9abf-a568e2a8a3deSPL set ID 1bf22e97-9425-484d-bac6-519c6bae6a37RxCUI 197900, 197901, 197902UNII 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
N400093342501followed by a unit qualifier and the quantityPackage 00093-3425-01. 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 tablets are 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.
About NDC 0093-3425
- What is NDC 0093-3425?
- 0093-3425 is the product NDC for Lorazepam, Lorazepam .5 mg/1 tablet, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lorazepam.
- What is the active ingredient?
- Lorazepam.
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lorazepam?
- 135 other product NDCs are listed under this name. See all Lorazepam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lorazepam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-091 | 87441-0091-01 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4180 | 68788-4180-0168788-4180-0368788-4180-06+2 more |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-948 | 60760-0948-02 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-947 | 60760-0947-02 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-050 | 87441-0050-01 |
| Lorazepam | Lorazepam 2 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-051 | 87441-0051-01 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | Coupler LLC | 67046-0230 | 67046-0230-03 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | Coupler LLC | 67046-0786 | 67046-0786-03 |
| Lorazepam | Lorazepam 2 mg/1 | TabletOral | Coupler LLC | 67046-0936 | 67046-0936-03 |
| Lorazepam | Lorazepam 2 mg/mL | LiquidOral | American Health Packaging | 68000-107 | 68000-0107-05 |
Other NDCs under ANDA 072926
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 | REMEDYREPACK INC. | 70518-3806 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-236 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-996 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | Coupler LLC | 67046-0786 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-654 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | Proficient Rx LP | 71205-756 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-050 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | Redpharm Drug | 67296-1478 |