NDC codes

FDA NDC Directory
Product NDC (as listed)0472-0082Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00472-0082Add 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
0472-0082-1600472008216473 mL in 1 BOTTLE (0472-0082-16)Marketed from Sep 3, 2002

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 200 mg/5mL
Dosage form
Suspension
Route
Oral
Labeler
Actavis Pharma, Inc.NDC labeler code 0472
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074738
Marketing start
Listing expires
Other FDA classes
DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers
Product ID 0472-0082_6f58843b-1a91-42b4-b03c-7cad93c931d6SPL ID 6f58843b-1a91-42b4-b03c-7cad93c931d6SPL set ID a4c1305c-f18c-4fb0-83d8-2822341f2dfaRxCUI 307730UNII X4HES1O11FUPC 0304720082163
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

N400472008216 followed by a unit qualifier and the quantity

Package 00472-0082-16. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Herpes Zoster Infections: Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir is indicated for the treatment of chickenpox (varicella).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0472-0082

What is NDC 0472-0082?
0472-0082 is the product NDC for Acyclovir, Acyclovir 200 mg/5mL suspension, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Acyclovir.
What is the active ingredient?
Acyclovir.
Who is the labeler?
Actavis Pharma, Inc., NDC labeler code 0472. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acyclovir?
194 other product NDCs are listed under this name. See all Acyclovir 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 Acyclovir NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
acyclovirAcyclovir 50 mg/gOintmentTopicalc68788-414268788-4142-01
AcyclovirAcyclovir 200 mg/1CapsuleOralCardinal Health 107, LLC55154-019955154-0199-00
acyclovirAcyclovir 800 mg/1TabletOralNorthwind Health Company, LLC82868-10782868-0107-3082868-0107-35
AcyclovirAcyclovir 50 mg/gOintmentTopicalAryeh Pharma Corp85957-03685957-0036-0185957-0036-0285957-0036-03
AcyclovirAcyclovir 200 mg/1CapsuleOralAvet Pharmaceuticals Inc.23155-96223155-0962-0123155-0962-05
AcyclovirAcyclovir 200 mg/1CapsuleOralFlorida Pharmaceutical Products, LLC71921-14671921-0146-01
AcyclovirAcyclovir 200 mg/1CapsuleOralMajor Pharmaceuticals0904-751900904-7519-61
AcyclovirAcyclovir 400 mg/1TabletOralAurobindo Pharma Limited59651-96559651-0965-0159651-0965-0559651-0965-10
AcyclovirAcyclovir 800 mg/1TabletOralAurobindo Pharma Limited59651-96659651-0966-0159651-0966-0559651-0966-10
AcyclovirAcyclovir 800 mg/1TabletOralREMEDYREPACK INC.70518-445070518-4450-0070518-4450-01

All 195 Acyclovir NDCs

Other NDCs under ANDA 074738

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

FDA NDC Directory listings under ANDA 074738
ProductStrengthForm · routeLabelerProduct NDC
AcyclovirAcyclovir 200 mg/5mLSuspensionOralATLANTIC BIOLOGICALS CORP.17856-0083
AcyclovirAcyclovir 200 mg/5mLSuspensionOralATLANTIC BIOLOGICALS CORP.17856-8083

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