What is NDC 76420-315?

76420-315 is the product NDC for Diazepam, Diazepam 5 mg/1 tablet, listed with the FDA by ASCLEMED USA INC.. It has 8 package NDCs, shown above in 10- and 11-digit form.

ASCLEMED USA INC., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Diazepam?

118 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Diazepam NDC 76420-315 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-315Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0315Add 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
76420-315-00	7642003150076420031500	1000 TABLET in 1 BOTTLE (76420-315-00)Marketed from Oct 31, 2025
76420-315-01	7642003150176420031501	100 TABLET in 1 BOTTLE (76420-315-01)Marketed from Oct 31, 2025
76420-315-05	7642003150576420031505	500 TABLET in 1 BOTTLE (76420-315-05)Marketed from Oct 31, 2025
76420-315-10	7642003151076420031510	10 TABLET in 1 BOTTLE (76420-315-10)Marketed from Oct 31, 2025
76420-315-20	7642003152076420031520	20 TABLET in 1 BOTTLE (76420-315-20)Marketed from Oct 31, 2025
76420-315-30	7642003153076420031530	30 TABLET in 1 BOTTLE (76420-315-30)Marketed from Oct 31, 2025
76420-315-60	7642003156076420031560	60 TABLET in 1 BOTTLE (76420-315-60)Marketed from Oct 31, 2025
76420-315-90	7642003159076420031590	90 TABLET in 1 BOTTLE (76420-315-90)Marketed from Oct 31, 2025

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): Diazepam
Generic name (nonproprietary): diazepam
Active ingredients: Diazepam — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: ASCLEMED USA INC.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217843
Marketing start: Dec 14, 2023
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 76420-315_42708657-5977-a009-e063-6294a90a3919SPL ID 42708657-5977-a009-e063-6294a90a3919SPL set ID 426f3da1-4105-ba0a-e063-6294a90a7a86RxCUI 197589, 197590, 197591UNII Q3JTX2Q7TU
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

N476420031500 followed by a unit qualifier and the quantity

Package 76420-0315-00. 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 Oct 31, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Diazepam tablets are indicated for the management of anxiety disorders or for the short- term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-315

What is NDC 76420-315?: 76420-315 is the product NDC for Diazepam, Diazepam 5 mg/1 tablet, listed with the FDA by ASCLEMED USA INC.. It has 8 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diazepam.
What is the active ingredient?: Diazepam.
Who is the labeler?: ASCLEMED USA INC., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Diazepam?: 118 other product NDCs are listed under this name. See all Diazepam 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 Diazepam NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Diazepam	Diazepam 5 mg/mL	InjectionIntramuscular, Intravenous	Civica, Inc.	72572-175	72572-0175-10
Diazepam	Diazepam 10 mg/2mL	Injection, SolutionIntramuscular, Intravenous	Baxter Healthcare Corporation	43066-121	43066-0121-10
Diazepam	Diazepam 20 mg/4mL	Injection, SolutionIntramuscular, Intravenous	Baxter Healthcare Corporation	43066-123	43066-0123-10
Diazepam	Diazepam 10 mg/2mL	Injection, SolutionIntramuscular, Intravenous	REMEDYREPACK INC.	70518-4704	70518-4704-00
Diazepam	Diazepam 5 mg/mL	Injection, SolutionIntramuscular, Intravenous	Hikma Pharmaceuticals USA Inc.	0641-6283	00641-6283-25
Diazepam	Diazepam 10 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-025	87441-0025-01
Diazepam	Diazepam 5 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-026	87441-0026-01
Diazepam	Diazepam 5 mg/1	TabletOral	Coupler LLC	67046-0943	67046-0943-03
Diazepam	Diazepam 10 mg/1	TabletOral	Coupler LLC	67046-0944	67046-0944-03
Diazepam	Diazepam 5 mg/mL	InjectionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9762	00404-9762-10

All 119 Diazepam NDCs

Other NDCs under ANDA 217843

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

FDA NDC Directory listings under ANDA 217843
Product	Strength	Form · route	Labeler	Product NDC
Diazepam	Diazepam 2 mg/1	TabletOral	Aurobindo Pharma Limited	59651-652
Diazepam	Diazepam 5 mg/1	TabletOral	Aurobindo Pharma Limited	59651-653
Diazepam	Diazepam 10 mg/1	TabletOral	Aurobindo Pharma Limited	59651-654
Diazepam	Diazepam 5 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3682
Diazepam	Diazepam 5 mg/1	TabletOral	NuCare Pharmaceuticals, Inc	68071-3686
Diazepam	Diazepam 2 mg/1	TabletOral	ASCLEMED USA INC.	76420-314
Diazepam	Diazepam 10 mg/1	TabletOral	ASCLEMED USA INC.	76420-316
Diazepam	Diazepam 10 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0511
Diazepam	Diazepam 10 mg/1	TabletOral	Proficient Rx LP	82804-186