NDC codes

FDA NDC Directory
Product NDC (as listed)63629-1523Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-1523Add 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
63629-1523-06362915230063629152300120 TABLET in 1 BOTTLE (63629-1523-0)Marketed from Jan 18, 2012
63629-1523-1636291523016362915230112 TABLET in 1 BOTTLE (63629-1523-1)Marketed from Oct 4, 2005
63629-1523-2636291523026362915230215 TABLET in 1 BOTTLE (63629-1523-2)Marketed from Apr 9, 2007
63629-1523-3636291523036362915230320 TABLET in 1 BOTTLE (63629-1523-3)Marketed from Nov 16, 2005
63629-1523-4636291523046362915230430 TABLET in 1 BOTTLE (63629-1523-4)Marketed from Apr 6, 2006
63629-1523-5636291523056362915230560 TABLET in 1 BOTTLE (63629-1523-5)Marketed from Feb 2, 2006
63629-1523-6636291523066362915230690 TABLET in 1 BOTTLE (63629-1523-6)Marketed from Jun 6, 2006
63629-1523-7636291523076362915230710 TABLET in 1 BOTTLE (63629-1523-7)Marketed from Oct 23, 2007
63629-1523-963629152309636291523091 TABLET in 1 BOTTLE (63629-1523-9)Marketed from Jul 23, 2008

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
Bryant Ranch PrepackNDC labeler code 63629
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 63629-1523_fc6ec7d9-ec72-4ba7-929f-0460f00e71dcSPL ID fc6ec7d9-ec72-4ba7-929f-0460f00e71dcSPL set ID e8e4d5f5-3b4c-4c0f-a818-9da86389473cRxCUI 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

N463629152300 followed by a unit qualifier and the quantity

Package 63629-1523-00. 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 . 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 63629-1523

What is NDC 63629-1523?
63629-1523 is the product NDC for Diazepam, Diazepam 5 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 9 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?
Bryant Ranch Prepack, NDC labeler code 63629. 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/1TabletOralClinical Solutions Wholesale, LLC58118-3926
DiazepamDiazepam 5 mg/1TabletOralDirect_Rx61919-409
DiazepamDiazepam 5 mg/1TabletOralProficient Rx LP63187-173
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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