What is NDC 13107-319?

13107-319 is the product NDC for Clorazepate Dipotassium, Clorazepate dipotassium 3.75 mg/1 tablet, listed with the FDA by Aurolife Pharma LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

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 Clorazepate Dipotassium?

24 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clorazepate Dipotassium NDC 13107-319 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)13107-319Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13107-0319Add 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
13107-319-01	13107031901	100 TABLET in 1 BOTTLE (13107-319-01)Marketed from Jul 17, 1987
13107-319-05	13107031905	500 TABLET in 1 BOTTLE, PLASTIC (13107-319-05)Marketed from Jul 17, 1987

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): Clorazepate Dipotassium
Generic name (nonproprietary): clorazepate dipotassium
Active ingredients: Clorazepate dipotassium — 3.75 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 071858
Marketing start: Jul 17, 1987
Marketing end: Feb 28, 2027
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 13107-319_5da093d0-dc77-4240-97f1-d1e0ccc622ffSPL ID 5da093d0-dc77-4240-97f1-d1e0ccc622ffSPL set ID 919cbd07-f587-4005-acff-26213dd1d1fbRxCUI 197464, 197465, 197466UNII 63FN7G03XYUPC 0313107319013, 0313107320019, 0313107321016
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

N413107031901 followed by a unit qualifier and the quantity

Package 13107-0319-01. 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 Mar 25, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clorazepate dipotassium tablets are indicatedfor the management of anxiety disordersorfortheshort-term relief of the symptoms of anxiety. Anxiety or tensionassociatedwith the stress of everyday life usually does not require treatmentwith an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctivetherapy in themanagement of partialseizures. Theeffectiveness of Clorazepate dipotassium tablets in long-term management of anxiety, that is,more than 4 months, has not beenassessed by systematicclinicalstudies.Long-term studies in epilepticpatients,however, have showncontinuedtherapeuticactivity.Thephysician should reassessperiodically the usefulnessof the drug f…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 13107-319

What is NDC 13107-319?: 13107-319 is the product NDC for Clorazepate Dipotassium, Clorazepate dipotassium 3.75 mg/1 tablet, listed with the FDA by Aurolife Pharma LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Clorazepate Dipotassium.
What is the active ingredient?: Clorazepate dipotassium.
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 Clorazepate Dipotassium?: 24 other product NDCs are listed under this name. See all Clorazepate Dipotassium 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 Clorazepate Dipotassium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Clorazepate Dipotassium	Clorazepate dipotassium 7.5 mg/1	TabletOral	Coupler LLC	67046-1601	67046-1601-03
Clorazepate Dipotassium	Clorazepate dipotassium 15 mg/1	TabletOral	Coupler LLC	67046-1462	67046-1462-03
Clorazepate Dipotassium	Clorazepate dipotassium 15 mg/1	TabletOral	Coupler LLC	67046-1501	67046-1501-03
Clorazepate Dipotassium	Clorazepate dipotassium 3.75 mg/1	TabletOral	Aurolife Pharma LLC	13107-282	13107-0282-0113107-0282-05
Clorazepate Dipotassium	Clorazepate dipotassium 7.5 mg/1	TabletOral	Aurolife Pharma LLC	13107-283	13107-0283-0113107-0283-05
Clorazepate Dipotassium	Clorazepate dipotassium 15 mg/1	TabletOral	Aurolife Pharma LLC	13107-284	13107-0284-01
Clorazepate Dipotassium	Clorazepate dipotassium 15 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	70954-157	70954-0157-1070954-0157-2070954-0157-40
Clorazepate Dipotassium	Clorazepate dipotassium 3.75 mg/1	TabletOral	NORTHSTAR RX LLC	72603-112	72603-0112-0172603-0112-02
Clorazepate Dipotassium	Clorazepate dipotassium 7.5 mg/1	TabletOral	NORTHSTAR RX LLC	72603-113	72603-0113-0172603-0113-02
Clorazepate Dipotassium	Clorazepate dipotassium 15 mg/1	TabletOral	NORTHSTAR RX LLC	72603-114	72603-0114-01

All 25 Clorazepate Dipotassium NDCs

Other NDCs under ANDA 071858

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

FDA NDC Directory listings under ANDA 071858
Product	Strength	Form · route	Labeler	Product NDC
Clorazepate Dipotassium	Clorazepate dipotassium 3.75 mg/1	TabletOral	Aurolife Pharma LLC	13107-282
Clorazepate Dipotassium	Clorazepate dipotassium 7.5 mg/1	TabletOral	Aurolife Pharma LLC	13107-283
Clorazepate Dipotassium	Clorazepate dipotassium 15 mg/1	TabletOral	Aurolife Pharma LLC	13107-284
Clorazepate Dipotassium	Clorazepate dipotassium 7.5 mg/1	TabletOral	Aurolife Pharma LLC	13107-320
Clorazepate Dipotassium	Clorazepate dipotassium 15 mg/1	TabletOral	Aurolife Pharma LLC	13107-321