NDC codes

FDA NDC Directory
Product NDC (as listed)69367-138Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69367-0138Add 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
69367-138-0169367013801100 TABLET in 1 BOTTLE (69367-138-01)Marketed from Jun 20, 2023
69367-138-0569367013805500 TABLET in 1 BOTTLE (69367-138-05)Marketed from Jun 20, 2023

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)
Acyclovir
Generic name (nonproprietary)
acyclovir
Active ingredients
Acyclovir — 800 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210401
Marketing start
Listing expires
Other FDA classes
DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers
Product ID 69367-138_629d8ddb-bba0-4dd8-8621-1bd2a7b129dcSPL ID 629d8ddb-bba0-4dd8-8621-1bd2a7b129dcSPL set ID f352a641-988e-4878-8016-2b69cd6ee548RxCUI 197311, 197313UNII X4HES1O11FUPC 0369367137010, 0369367138017
Pharmacologic class
Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor; Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor; Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor

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

N469367013801 followed by a unit qualifier and the quantity

Package 69367-0138-01. 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 210401

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

FDA NDC Directory listings under ANDA 210401
ProductStrengthForm · routeLabelerProduct NDC
AcyclovirAcyclovir 400 mg/1TabletOralBryant Ranch Prepack71335-3103
AcyclovirAcyclovir 800 mg/1TabletOralChartwell RX, LLC62135-019
AcyclovirAcyclovir 400 mg/1TabletOralRedpharm Drug67296-2162
AcyclovirAcyclovir 400 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-587
AcyclovirAcyclovir 400 mg/1TabletOralProficient Rx LP71205-472
AcyclovirAcyclovir 400 mg/1TabletOralProficient Rx LP82804-005
AcyclovirAcyclovir 800 mg/1TabletOralRedpharm Drug67296-2254
AcyclovirAcyclovir 800 mg/1TabletOralProficient Rx LP82804-012
AcyclovirAcyclovir 800 mg/1TabletOralA-S Medication Solutions50090-6578
AcyclovirAcyclovir 800 mg/1TabletOralBryant Ranch Prepack71335-1222
AcyclovirAcyclovir 400 mg/1TabletOralWestminster Pharmaceuticals, LLC69367-137
AcyclovirAcyclovir 400 mg/1TabletOralA-S Medication Solutions50090-7276
AcyclovirAcyclovir 400 mg/1TabletOralA-S Medication Solutions50090-7275
AcyclovirAcyclovir 400 mg/1TabletOralA-S Medication Solutions50090-7277
AcyclovirAcyclovir 400 mg/1TabletOralPreferred Pharmaceuticals Inc68788-8724
AcyclovirAcyclovir 400 mg/1TabletOralYILING PHARMACEUTICAL, INC.69117-0018
AcyclovirAcyclovir 800 mg/1TabletOralYILING PHARMACEUTICAL, INC.69117-0019

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