NDC codes

FDA NDC Directory
Product NDC (as listed)76420-783Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76420-0783Add 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
76420-783-0176420078301100 TABLET in 1 BOTTLE (76420-783-01)Marketed from Mar 8, 2024
76420-783-02764200783022 TABLET in 1 BOTTLE (76420-783-02)Marketed from Jan 27, 2025
76420-783-03764200783033 TABLET in 1 BOTTLE (76420-783-03)Marketed from Jan 27, 2025
76420-783-05764200783055 TABLET in 1 BOTTLE (76420-783-05)Marketed from Jan 27, 2025
76420-783-107642007831010 TABLET in 1 BOTTLE (76420-783-10)Marketed from Jan 27, 2025
76420-783-207642007832020 TABLET in 1 BOTTLE (76420-783-20)Marketed from Jan 27, 2025
76420-783-307642007833030 TABLET in 1 BOTTLE (76420-783-30)Marketed from Mar 8, 2024
76420-783-5576420078355500 TABLET in 1 BOTTLE (76420-783-55)Marketed from Jan 27, 2025
76420-783-607642007836060 TABLET in 1 BOTTLE (76420-783-60)Marketed from Mar 8, 2024
76420-783-907642007839090 TABLET in 1 BOTTLE (76420-783-90)Marketed from Mar 8, 2024

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 — 2 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 071307
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Benzodiazepines (Chemical structure)
Identifiers
Product ID 76420-783_2cb3e981-e5b2-9d49-e063-6394a90abfbdSPL ID 2cb3e981-e5b2-9d49-e063-6394a90abfbdSPL set ID 32e7bfa1-6060-4041-a0e5-249cacb84ebcRxCUI 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

N476420078301 followed by a unit qualifier and the quantity

Package 76420-0783-01. 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 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 is 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 and paraplegia), at…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-783

What is NDC 76420-783?
76420-783 is the product NDC for Diazepam, Diazepam 2 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 10 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DiazepamDiazepam 5 mg/mLInjectionIntramuscular, IntravenousCivica, Inc.72572-17572572-0175-10
DiazepamDiazepam 10 mg/2mLInjection, SolutionIntramuscular, IntravenousBaxter Healthcare Corporation43066-12143066-0121-10
DiazepamDiazepam 20 mg/4mLInjection, SolutionIntramuscular, IntravenousBaxter Healthcare Corporation43066-12343066-0123-10
DiazepamDiazepam 10 mg/2mLInjection, SolutionIntramuscular, IntravenousREMEDYREPACK INC.70518-470470518-4704-00
DiazepamDiazepam 5 mg/mLInjection, SolutionIntramuscular, IntravenousHikma Pharmaceuticals USA Inc.0641-628300641-6283-25
DiazepamDiazepam 5 mg/1TabletOralUnit Dose Solutions, Inc.87441-02687441-0026-01
DiazepamDiazepam 10 mg/1TabletOralUnit Dose Solutions, Inc.87441-02587441-0025-01
DiazepamDiazepam 10 mg/1TabletOralCoupler LLC67046-094467046-0944-03
DiazepamDiazepam 5 mg/1TabletOralCoupler LLC67046-094367046-0943-03
DiazepamDiazepam 5 mg/mLInjectionIntramuscular, IntravenousHenry Schein, Inc.0404-976200404-9762-10

All 119 Diazepam NDCs

Other NDCs under ANDA 071307

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

FDA NDC Directory listings under ANDA 071307
ProductStrengthForm · routeLabelerProduct NDC
DiazepamDiazepam 2 mg/1TabletOralClinical Solutions Wholesale, LLC58118-3925
DiazepamDiazepam 2 mg/1TabletOralA-S Medication Solutions50090-0195
DiazepamDiazepam 2 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0172-3925
DiazepamDiazepam 2 mg/1TabletOralBryant Ranch Prepack63629-2948
DiazepamDiazepam 2 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-840
DiazepamDiazepam 2 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC43353-825

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