NDC codes

FDA NDC Directory
Product NDC (as listed)0143-9657Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00143-9657Add 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
0143-9657-10001439657100014396571010 VIAL, SINGLE-DOSE in 1 BOX (0143-9657-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9657-01)Marketed from Feb 29, 2016

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 sodium — 500 mg/1
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
Labeler
Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205771
Marketing start
Listing expires
Other FDA classes
DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers
Product ID 0143-9657_dbf69540-34d6-423d-a06a-e5eddfd40ae3SPL ID dbf69540-34d6-423d-a06a-e5eddfd40ae3SPL set ID babdbce2-5cbd-4943-bc38-9ebdd696a77aRxCUI 2263503, 2263505UNII 927L42J563
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400143965710 followed by a unit qualifier and the quantity

Package 00143-9657-10. 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 Simplex Infections in Immunocompromised Patients Acyclovir for Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients. Initial Episodes of Herpes Genitalis Acyclovir for Injection is indicated for the treatment of severe initial clinical episodes of herpes genitalis in immunocompetent patients. Herpes Simplex Encephalitis Acyclovir for Injection is indicated for the treatment of herpes simplex encephalitis. Neonatal Herpes Simplex Virus Infection Acyclovir for Injection is indicated for the treatment of neonatal herpes infections. Varicella-Zoster Infections in Immunoc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0143-9657

What is NDC 0143-9657?
0143-9657 is the product NDC for Acyclovir, Acyclovir sodium 500 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Hikma Pharmaceuticals USA 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 sodium.
Who is the labeler?
Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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?
193 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 800 mg/1TabletOralAurobindo Pharma Limited59651-96659651-0966-0159651-0966-0559651-0966-10
AcyclovirAcyclovir 400 mg/1TabletOralAurobindo Pharma Limited59651-96559651-0965-0159651-0965-0559651-0965-10
AcyclovirAcyclovir 800 mg/1TabletOralREMEDYREPACK INC.70518-445070518-4450-0070518-4450-01

All 194 Acyclovir NDCs

Other NDCs under ANDA 205771

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

FDA NDC Directory listings under ANDA 205771
ProductStrengthForm · routeLabelerProduct NDC
AcyclovirAcyclovir sodium 1 g/1Injection, Powder, Lyophilized, For solutionIntravenousHikma Pharmaceuticals USA Inc.0143-9658

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