What is NDC 71610-225?

71610-225 is the product NDC for Lorazepam, Lorazepam .5 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 11 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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?

133 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 71610-225 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-225Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0225Add 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
71610-225-10	7161002251071610022510	10 TABLET in 1 BOTTLE (71610-225-10)Marketed from Nov 2, 2023
71610-225-15	7161002251571610022515	15 TABLET in 1 BOTTLE (71610-225-15)Marketed from May 16, 2023
71610-225-20	7161002252071610022520	20 TABLET in 1 BOTTLE (71610-225-20)Marketed from Nov 2, 2023
71610-225-28	7161002252871610022528	28 TABLET in 1 BOTTLE (71610-225-28)Marketed from Apr 12, 2024
71610-225-30	7161002253071610022530	30 TABLET in 1 BOTTLE (71610-225-30)Marketed from May 16, 2023
71610-225-45	7161002254571610022545	45 TABLET in 1 BOTTLE (71610-225-45)Marketed from May 16, 2023
71610-225-53	7161002255371610022553	60 TABLET in 1 BOTTLE (71610-225-53)Marketed from May 16, 2023
71610-225-60	7161002256071610022560	90 TABLET in 1 BOTTLE (71610-225-60)Marketed from May 16, 2023
71610-225-70	7161002257071610022570	120 TABLET in 1 BOTTLE (71610-225-70)Marketed from Jun 19, 2023
71610-225-75	7161002257571610022575	150 TABLET in 1 BOTTLE (71610-225-75)Marketed from Jun 19, 2023
71610-225-80	7161002258071610022580	180 TABLET in 1 BOTTLE (71610-225-80)Marketed from May 16, 2023

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 — .5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078203
Marketing start: May 16, 2023
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 71610-225_15ea852c-5478-544b-e063-6394a90a1ac5SPL ID 15ea852c-5478-544b-e063-6394a90a1ac5SPL set ID e563594e-212c-4f31-92ea-294aeab45df3RxCUI 197900UNII 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

N471610022510 followed by a unit qualifier and the quantity

Package 71610-0225-10. 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 Apr 12, 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 71610-225

What is NDC 71610-225?: 71610-225 is the product NDC for Lorazepam, Lorazepam .5 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 11 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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?: 133 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 .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

All 134 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 1 mg/1	TabletOral	REMEDYREPACK INC.	70518-0275
Lorazepam	Lorazepam 1 mg/1	TabletOral	Proficient Rx LP	71205-235
Lorazepam	Lorazepam 2 mg/1	TabletOral	REMEDYREPACK INC.	70518-0445
Lorazepam	Lorazepam 1 mg/1	TabletOral	REMEDYREPACK INC.	70518-0486
Lorazepam	Lorazepam 1 mg/1	TabletOral	A-S Medication Solutions	50090-5508
Lorazepam	Lorazepam .5 mg/1	TabletOral	Asclemed USA, Inc.	76420-647
Lorazepam	Lorazepam 1 mg/1	TabletOral	A-S Medication Solutions	50090-5509
Lorazepam	Lorazepam .5 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3096
Lorazepam	Lorazepam .5 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3121
Lorazepam	Lorazepam 2 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-197
Lorazepam	Lorazepam 1 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3227
Lorazepam	Lorazepam .5 mg/1	TabletOral	Leading Pharma, LLC	69315-904
Lorazepam	Lorazepam 1 mg/1	TabletOral	Leading Pharma, LLC	69315-905
Lorazepam	Lorazepam 2 mg/1	TabletOral	Leading Pharma, LLC	69315-906
Lorazepam	Lorazepam 1 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3242
Lorazepam	Lorazepam .5 mg/1	TabletOral	DIRECT RX	61919-062
Lorazepam	Lorazepam .5 mg/1	TabletOral	Bryant Ranch Prepack	71335-0329
Lorazepam	Lorazepam 1 mg/1	TabletOral	PharmPak, Inc.	54348-049
Lorazepam	Lorazepam 1 mg/1	TabletOral	REMEDYREPACK INC.	70518-2442

Showing 20 of 32.