NDC codes

FDA NDC Directory
Product NDC (as listed)43063-987Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0987Add 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
43063-987-02430630987022 TABLET in 1 BOTTLE, PLASTIC (43063-987-02)Marketed from Sep 23, 2020
43063-987-204306309872020 TABLET in 1 BOTTLE, PLASTIC (43063-987-20)Marketed from May 23, 2020
43063-987-304306309873030 TABLET in 1 BOTTLE, PLASTIC (43063-987-30)Marketed from May 30, 2020
43063-987-604306309876060 TABLET in 1 BOTTLE, PLASTIC (43063-987-60)Marketed from May 30, 2020

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 — 10 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 071322
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Benzodiazepines (Chemical structure)
Identifiers
Product ID 43063-987_415f8162-1d01-9092-e063-6394a90ace01SPL ID 415f8162-1d01-9092-e063-6394a90ace01SPL set ID 84cecab3-d0e6-436b-996b-0b598e972308RxCUI 197589UNII Q3JTX2Q7TUUPC 0343063987605
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

N443063098702 followed by a unit qualifier and the quantity

Package 43063-0987-02. 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 43063-987

What is NDC 43063-987?
43063-987 is the product NDC for Diazepam, Diazepam 10 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 4 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?
116 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 117 Diazepam NDCs

Other NDCs under ANDA 071322

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

FDA NDC Directory listings under ANDA 071322
ProductStrengthForm · routeLabelerProduct NDC
DiazepamDiazepam 10 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0172-3927
DiazepamDiazepam 10 mg/1TabletOralA-S Medication Solutions50090-1726
DiazepamDiazepam 10 mg/1TabletOralDirect_Rx61919-906
DiazepamDiazepam 10 mg/1TabletOralProficient Rx LP63187-544
DiazepamDiazepam 10 mg/1TabletOralCoupler LLC67046-0944
DiazepamDiazepam 10 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4829
DiazepamDiazepam 10 mg/1TabletOralREMEDYREPACK INC.70518-0014
DiazepamDiazepam 10 mg/1TabletOralREMEDYREPACK INC.70518-0162
DiazepamDiazepam 10 mg/1TabletOralBryant Ranch Prepack71335-0444
DiazepamDiazepam 10 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-424
DiazepamDiazepam 10 mg/1TabletOralAsclemed USA, Inc.76420-784
DiazepamDiazepam 10 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0120

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