NDC codes

FDA NDC Directory
Product NDC (as listed)65841-803Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65841-0803Add 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
65841-803-0165841080301100 TABLET in 1 BOTTLE (65841-803-01)Marketed from Sep 10, 2014
65841-803-0565841080305500 TABLET in 1 BOTTLE (65841-803-05)Marketed from Sep 10, 2014
65841-803-066584108030630 TABLET in 1 BOTTLE (65841-803-06)Marketed from Sep 10, 2014
65841-803-10658410803101000 TABLET in 1 BOTTLE (65841-803-10)Marketed from Sep 10, 2014
65841-803-166584108031690 TABLET in 1 BOTTLE (65841-803-16)Marketed from Sep 10, 2014
65841-803-306584108033010 BLISTER PACK in 1 CARTON (65841-803-30) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 10, 2014

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
Labeler
Zydus Lifesciences LimitedNDC labeler code 65841
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204314
Marketing start
Listing expires
Other FDA classes
DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers
Product ID 65841-803_b401b7c4-9c22-470f-981e-da74bef39dc6SPL ID b401b7c4-9c22-470f-981e-da74bef39dc6SPL set ID 8d9fea43-6c04-40d7-8aac-398c2de2a558RxCUI 197311, 197313UNII X4HES1O11FUPC 0365841803013
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

N465841080301 followed by a unit qualifier and the quantity

Package 65841-0803-01. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE Herpes Zoster Infections: Acyclovir tablets are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets are 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 65841-803

What is NDC 65841-803?
65841-803 is the product NDC for acyclovir, Acyclovir 800 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 6 package NDCs, 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?
Zydus Lifesciences Limited, NDC labeler code 65841. 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 204314

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

FDA NDC Directory listings under ANDA 204314
ProductStrengthForm · routeLabelerProduct NDC
acyclovirAcyclovir 400 mg/1TabletOralA-S Medication Solutions50090-3250
acyclovirAcyclovir 400 mg/1TabletOralA-S Medication Solutions50090-3254
acyclovirAcyclovir 800 mg/1TabletOralProficient Rx LP63187-366
acyclovirAcyclovir 400 mg/1TabletOralZydus Lifesciences Limited65841-802
acyclovirAcyclovir 800 mg/1TabletOralNuCare Pharmaceuticals, Inc.66267-399
acyclovirAcyclovir 800 mg/1TabletOralCoupler LLC67046-1487
acyclovirAcyclovir 400 mg/1TabletOralZydus Pharmaceuticals (USA) Inc.68382-791
acyclovirAcyclovir 800 mg/1TabletOralZydus Pharmaceuticals (USA) Inc.68382-792
acyclovirAcyclovir 400 mg/1TabletOralREMEDYREPACK INC.70518-1363
acyclovirAcyclovir 800 mg/1TabletOralREMEDYREPACK INC.70518-1614
acyclovirAcyclovir 800 mg/1TabletOralNorthwind Health Company, LLC82868-107

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