NDC codes

FDA NDC Directory
Product NDC (as listed)13107-084Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13107-0084Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
13107-084-011310700840113107008401100 TABLET in 1 BOTTLE (13107-084-01)Marketed from Feb 1, 2021
13107-084-051310700840513107008405500 TABLET in 1 BOTTLE (13107-084-05)Marketed from Feb 1, 2021
13107-084-10131070084101310700841010 TABLET in 1 BOTTLE (13107-084-10)Marketed from Feb 1, 2021
13107-084-9913107008499131070084991000 TABLET in 1 BOTTLE (13107-084-99)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 — 1 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 13107-084_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

N413107008401 followed by a unit qualifier and the quantity

Package 13107-0084-01. 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.

Full label on DailyMed (opens in a new tab)

About NDC 13107-084

What is NDC 13107-084?
13107-084 is the product NDC for Lorazepam, Lorazepam 1 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Lorazepam NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LorazepamLorazepam 1 mg/1TabletOralUnit Dose Solutions, Inc.87441-09187441-0091-01
LorazepamLorazepam 1 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-418068788-4180-0168788-4180-0368788-4180-06+2 more
LorazepamLorazepam .5 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-94760760-0947-02
LorazepamLorazepam 1 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-94860760-0948-02
LorazepamLorazepam .5 mg/1TabletOralUnit Dose Solutions, Inc.87441-05087441-0050-01
LorazepamLorazepam 2 mg/1TabletOralUnit Dose Solutions, Inc.87441-05187441-0051-01
LorazepamLorazepam 1 mg/1TabletOralCoupler LLC67046-023067046-0230-03
LorazepamLorazepam .5 mg/1TabletOralCoupler LLC67046-078667046-0786-03
LorazepamLorazepam 2 mg/1TabletOralCoupler LLC67046-093667046-0936-03
LorazepamLorazepam 2 mg/mLLiquidOralAmerican Health Packaging68000-10768000-0107-05

All 135 Lorazepam NDCs

Other NDCs under ANDA 203572

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203572
ProductStrengthForm · routeLabelerProduct NDC
LorazepamLorazepam 1 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-4180
LorazepamLorazepam 1 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-5022
LorazepamLorazepam .5 mg/1TabletOralAmerican Health Packaging60687-820
LorazepamLorazepam .5 mg/1TabletOralProficient Rx LP71205-228
LorazepamLorazepam .5 mg/1TabletOralAurolife Pharma LLC13107-083
LorazepamLorazepam 2 mg/1TabletOralAurolife Pharma LLC13107-085
LorazepamLorazepam 1 mg/1TabletOralAmerican Health Packaging60687-831
LorazepamLorazepam .5 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-5068
LorazepamLorazepam 1 mg/1TabletOralBryant Ranch Prepack71335-1694
LorazepamLorazepam 2 mg/1TabletOralAmerican Health Packaging60687-842
LorazepamLorazepam 1 mg/1TabletOralA-S Medication Solutions50090-5562
LorazepamLorazepam 1 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0465
LorazepamLorazepam 1 mg/1TabletOralA-S Medication Solutions50090-5563
LorazepamLorazepam .5 mg/1TabletOralDirectRx72189-351
LorazepamLorazepam 1 mg/1TabletOralREMEDYREPACK INC.70518-3870
LorazepamLorazepam .5 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-7355
LorazepamLorazepam 1 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-7428
LorazepamLorazepam 1 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-5250
LorazepamLorazepam .5 mg/1TabletOralBryant Ranch Prepack71335-1455
LorazepamLorazepam 2 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-7533

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