Prescription drug · ANDA
Lorazepam NDC 13107-085
Lorazepam 2 mg/1 · Tablet · Oral · Aurolife Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13107-085-01 | 1310700850113107008501 | 100 TABLET in 1 BOTTLE (13107-085-01)Marketed from Feb 1, 2021 | |
| 13107-085-05 | 1310700850513107008505 | 500 TABLET in 1 BOTTLE (13107-085-05)Marketed from Feb 1, 2021 | |
| 13107-085-10 | 1310700851013107008510 | 10 TABLET in 1 BOTTLE (13107-085-10)Marketed from Feb 1, 2021 | |
| 13107-085-99 | 1310700859913107008599 | 1000 TABLET in 1 BOTTLE (13107-085-99)Marketed from Feb 1, 2021 |
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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurolife Pharma LLCNDC labeler code 13107
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203572
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 13107-085_67012944-0947-4e64-adab-869993f2f709SPL ID 67012944-0947-4e64-adab-869993f2f709SPL set ID 5b851f67-309d-4ef3-8b4b-ade8908256eaRxCUI 197900, 197901, 197902UNII O26FZP769LUPC 0313107083013, 0313107084010, 0313107085017
- 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
N413107008501followed by a unit qualifier and the quantityPackage 13107-0085-01. 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 areindicated for the management of anxietydisorders or for theshort-termrelief of the symptoms of anxiety or anxietyassociatedwithdepressivesymptoms.Anxiety or tensionassociatedwith the stress of everyday life usuallydoesnotrequiretreatmentwith an anxiolytic. The effectiveness of lorazepam tablets in long-termuse,thatis,morethan 4 months,has not been assessed by systematicclinicalstudies. The physicianshouldperiodicallyreassess the usefulness of the drug for the individualpatient.
Excerpt only. Read the full label for complete information.
About NDC 13107-085
- What is NDC 13107-085?
- 13107-085 is the product NDC for Lorazepam, Lorazepam 2 mg/1 tablet, listed with the FDA by Aurolife Pharma LLC. It has 4 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?
- Aurolife Pharma LLC, NDC labeler code 13107. 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?
- 134 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 .5 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-947 | 60760-0947-02 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-948 | 60760-0948-02 |
| 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 203572
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 1 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4180 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5022 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | American Health Packaging | 60687-820 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | Proficient Rx LP | 71205-228 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | Aurolife Pharma LLC | 13107-083 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | Aurolife Pharma LLC | 13107-084 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | American Health Packaging | 60687-831 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5068 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1694 |
| Lorazepam | Lorazepam 2 mg/1 | TabletOral | American Health Packaging | 60687-842 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-5562 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0465 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-5563 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | DirectRx | 72189-351 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3870 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7355 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7428 |
| Lorazepam | Lorazepam 1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5250 |
| Lorazepam | Lorazepam .5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1455 |
| Lorazepam | Lorazepam 2 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7533 |
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