NDC codes

FDA NDC Directory
Product NDC (as listed)68071-3682Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-3682Add 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
68071-3682-16807136820110 TABLET in 1 BOTTLE (68071-3682-1)Marketed from Sep 6, 2024
68071-3682-6680713682066 TABLET in 1 BOTTLE (68071-3682-6)Marketed from Sep 6, 2024

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217843
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Benzodiazepines (Chemical structure)
Identifiers
Product ID 68071-3682_2a3162ec-9701-d87d-e063-6394a90adbd3SPL ID 2a3162ec-9701-d87d-e063-6394a90adbd3SPL set ID 21785bb2-cc96-7973-e063-6294a90ab1b8RxCUI 197591UNII Q3JTX2Q7TUUPC 0368071368260
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

N468071368201 followed by a unit qualifier and the quantity

Package 68071-3682-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 217843

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

FDA NDC Directory listings under ANDA 217843
ProductStrengthForm · routeLabelerProduct NDC
DiazepamDiazepam 5 mg/1TabletOralAurobindo Pharma Limited59651-653
DiazepamDiazepam 2 mg/1TabletOralAurobindo Pharma Limited59651-652
DiazepamDiazepam 10 mg/1TabletOralAurobindo Pharma Limited59651-654
DiazepamDiazepam 2 mg/1TabletOralASCLEMED USA INC.76420-314
DiazepamDiazepam 5 mg/1TabletOralASCLEMED USA INC.76420-315
DiazepamDiazepam 10 mg/1TabletOralASCLEMED USA INC.76420-316
DiazepamDiazepam 10 mg/1TabletOralProficient Rx LP82804-186
DiazepamDiazepam 10 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0511
DiazepamDiazepam 5 mg/1TabletOralNuCare Pharmaceuticals, Inc68071-3686

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