NDC codes

FDA NDC Directory
Product NDC (as listed)43063-970Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0970Add 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
43063-970-0443063097004430630970044 TABLET in 1 BOTTLE, PLASTIC (43063-970-04)Marketed from Jul 31, 2019
43063-970-0643063097006430630970066 TABLET in 1 BOTTLE, PLASTIC (43063-970-06)Marketed from May 13, 2019
43063-970-10430630970104306309701010 TABLET in 1 BOTTLE, PLASTIC (43063-970-10)Marketed from Aug 5, 2020
43063-970-15430630970154306309701515 TABLET in 1 BOTTLE, PLASTIC (43063-970-15)Marketed from Dec 4, 2019
43063-970-21430630970214306309702121 TABLET in 1 BOTTLE, PLASTIC (43063-970-21)Marketed from May 7, 2019
43063-970-30430630970304306309703030 TABLET in 1 BOTTLE, PLASTIC (43063-970-30)Marketed from May 1, 2019
43063-970-60430630970604306309706060 TABLET in 1 BOTTLE, PLASTIC (43063-970-60)Marketed from Nov 26, 2019

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
PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
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 43063-970_415f6daf-09f1-78a5-e063-6294a90a9553SPL ID 415f6daf-09f1-78a5-e063-6294a90a9553SPL set ID 2483426d-3782-432a-8b8d-86c06ef0de4aRxCUI 197591UNII Q3JTX2Q7TUUPC 0343063970300
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

N443063097004 followed by a unit qualifier and the quantity

Package 43063-0970-04. 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 43063-970

What is NDC 43063-970?
43063-970 is the product NDC for Diazepam, Diazepam 5 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 7 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?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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/1TabletOralA-S Medication Solutions50090-1913
DiazepamDiazepam 5 mg/1TabletOralA-S Medication Solutions50090-2249
DiazepamDiazepam 5 mg/1TabletOralClinical Solutions Wholesale, LLC58118-3926
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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