NDC codes

FDA NDC Directory
Product NDC (as listed)58118-3926Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58118-3926Add 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
58118-3926-8581183926085811839260830 TABLET in 1 BLISTER PACK (58118-3926-8)Marketed from Aug 1, 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)
Diazepam
Generic name (nonproprietary)
diazepam
Active ingredients
Diazepam — 5 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 071321
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Benzodiazepines (Chemical structure)
Identifiers
Product ID 58118-3926_0e85da3b-5f92-55cd-e063-6394a90a7599SPL ID 0e85da3b-5f92-55cd-e063-6394a90a7599SPL set ID 87b0fbb9-0c05-4ab0-8efe-7ffcae85b868RxCUI 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

N458118392608 followed by a unit qualifier and the quantity

Package 58118-3926-08. 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 . 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 58118-3926

What is NDC 58118-3926?
58118-3926 is the product NDC for Diazepam, Diazepam 5 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?
Diazepam.
What is the active ingredient?
Diazepam.
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 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 10 mg/1TabletOralUnit Dose Solutions, Inc.87441-02587441-0025-01
DiazepamDiazepam 5 mg/1TabletOralUnit Dose Solutions, Inc.87441-02687441-0026-01
DiazepamDiazepam 5 mg/1TabletOralCoupler LLC67046-094367046-0943-03
DiazepamDiazepam 10 mg/1TabletOralCoupler LLC67046-094467046-0944-03
DiazepamDiazepam 5 mg/mLInjectionIntramuscular, IntravenousHenry Schein, Inc.0404-976200404-9762-10

All 119 Diazepam NDCs

Other NDCs under ANDA 071321

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

FDA NDC Directory listings under ANDA 071321
ProductStrengthForm · routeLabelerProduct NDC
DiazepamDiazepam 5 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0172-3926
DiazepamDiazepam 5 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-970
DiazepamDiazepam 5 mg/1TabletOralA-S Medication Solutions50090-1913
DiazepamDiazepam 5 mg/1TabletOralA-S Medication Solutions50090-2249
DiazepamDiazepam 5 mg/1TabletOralDirect_Rx61919-409
DiazepamDiazepam 5 mg/1TabletOralProficient Rx LP63187-173
DiazepamDiazepam 5 mg/1TabletOralBryant Ranch Prepack63629-1523
DiazepamDiazepam 5 mg/1TabletOralCoupler LLC67046-0943
DiazepamDiazepam 5 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4770
DiazepamDiazepam 5 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4922
DiazepamDiazepam 5 mg/1TabletOralREMEDYREPACK INC.70518-1713
DiazepamDiazepam 5 mg/1TabletOralBryant Ranch Prepack71335-1584
DiazepamDiazepam 5 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-270
DiazepamDiazepam 5 mg/1TabletOralAsclemed USA, Inc.76420-533

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