What is NDC 58118-1095?

58118-1095 is the product NDC for Lorazepam, Lorazepam 1 mg/1 tablet, listed with the FDA by Clinical Solutions Wholesale, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Clinical Solutions Wholesale, LLC, NDC labeler code 58118. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lorazepam NDC 58118-1095 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58118-1095Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58118-1095Add 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 NDC	11-digit (billing)	Package	Copy
58118-1095-8	58118109508	30 TABLET in 1 BLISTER PACK (58118-1095-8)Marketed from Feb 15, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Clinical Solutions Wholesale, LLCNDC labeler code 58118
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078203
Marketing start: Feb 15, 2019
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 58118-1095_0e85cd9d-0f29-8950-e063-6294a90a33f7SPL ID 0e85cd9d-0f29-8950-e063-6294a90a33f7SPL set ID fdc11b95-2233-42b4-b5f3-9390b5e9e1b2RxCUI 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

N458118109508 followed by a unit qualifier and the quantity

Package 58118-1095-08. 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 Jan 9, 2024. 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.

Full label on DailyMed (opens in a new tab)

About NDC 58118-1095

What is NDC 58118-1095?: 58118-1095 is the product NDC for Lorazepam, Lorazepam 1 mg/1 tablet, listed with the FDA by Clinical Solutions Wholesale, LLC. It has 1 package NDC, 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?: Clinical Solutions Wholesale, LLC, NDC labeler code 58118. 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.

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

Other Lorazepam NDCs
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 2 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-051	87441-0051-01
Lorazepam	Lorazepam .5 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-050	87441-0050-01
Lorazepam	Lorazepam 1 mg/1	TabletOral	Coupler LLC	67046-0230	67046-0230-03
Lorazepam	Lorazepam 2 mg/1	TabletOral	Coupler LLC	67046-0936	67046-0936-03
Lorazepam	Lorazepam .5 mg/1	TabletOral	Coupler LLC	67046-0786	67046-0786-03
Lorazepam	Lorazepam 2 mg/mL	LiquidOral	American Health Packaging	68000-107	68000-0107-05

All 136 Lorazepam NDCs

Other NDCs under ANDA 078203

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

FDA NDC Directory listings under ANDA 078203
Product	Strength	Form · route	Labeler	Product NDC
Lorazepam	Lorazepam 1 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-255
Lorazepam	Lorazepam 2 mg/1	TabletOral	Coupler LLC	67046-0936
Lorazepam	Lorazepam .5 mg/1	TabletOral	REMEDYREPACK INC.	70518-1520
Lorazepam	Lorazepam 2 mg/1	TabletOral	REMEDYREPACK INC.	70518-1679
Lorazepam	Lorazepam 2 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-197
Lorazepam	Lorazepam .5 mg/1	TabletOral	Asclemed USA, Inc.	76420-647
Lorazepam	Lorazepam 1 mg/1	TabletOral	REMEDYREPACK INC.	70518-0275
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	NuCare Pharmaceuticals, Inc.	68071-3096
Lorazepam	Lorazepam .5 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3121
Lorazepam	Lorazepam .5 mg/1	TabletOral	RedPharm Drug, Inc.	67296-1629
Lorazepam	Lorazepam 1 mg/1	TabletOral	Proficient Rx LP	71205-235
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	NuCare Pharmaceuticals, Inc.	68071-3242
Lorazepam	Lorazepam .5 mg/1	TabletOral	DIRECT RX	61919-062

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