What is NDC 68382-049?

68382-049 is the product NDC for acyclovir, Acyclovir sodium 50 mg/mL injection, solution, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals (USA) Inc., NDC labeler code 68382. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

acyclovir NDC 68382-049 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-049Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0049Add 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 NDC	11-digit (billing)	Package	Copy
68382-049-10	6838200491068382004910	10 VIAL, SINGLE-USE in 1 CARTON (68382-049-10) / 20 mL in 1 VIAL, SINGLE-USE (68382-049-01)Marketed from Nov 27, 2018

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 sodium — 50 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Zydus Pharmaceuticals (USA) Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206535
Marketing start: Nov 27, 2018
Listing expires: Dec 31, 2027
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 68382-049_515388e8-636f-42f6-a39e-bb4fc7c2e7cbSPL ID 515388e8-636f-42f6-a39e-bb4fc7c2e7cbSPL set ID 69a98000-adef-4323-89a7-09e035a257d4RxCUI 1734932, 1734934UNII 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

N468382004910 followed by a unit qualifier and the quantity

Package 68382-0049-10. 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 Nov 29, 2021.

Indications (excerpt from the label)

INDICATIONS AND USAGE Herpes Simplex Infections in Immunocompromised Patients Acyclovir Sodium 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 Sodium Injection is indicated for the treatment of severe initial clinical episodes of herpes genitalis in immunocompetent patients. Herpes Simplex Encephalitis Acyclovir Sodium Injection is indicated for the treatment of herpes simplex encephalitis. Neonatal Herpes Simplex Virus Infection Acyclovir Sodium Injection is indicated for the treatment of neonates and infants with herpes simplex infections. V…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-049

What is NDC 68382-049?: 68382-049 is the product NDC for acyclovir, Acyclovir sodium 50 mg/mL injection, solution, listed with the FDA by Zydus 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?: Zydus Pharmaceuticals (USA) Inc., NDC labeler code 68382. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
acyclovir	Acyclovir 50 mg/g	OintmentTopical	c	68788-4142	68788-4142-01
Acyclovir	Acyclovir 200 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-0199	55154-0199-00
acyclovir	Acyclovir 800 mg/1	TabletOral	Northwind Health Company, LLC	82868-107	82868-0107-3082868-0107-35
Acyclovir	Acyclovir 50 mg/g	OintmentTopical	Aryeh Pharma Corp	85957-036	85957-0036-0185957-0036-0285957-0036-03
Acyclovir	Acyclovir 200 mg/1	CapsuleOral	Avet Pharmaceuticals Inc.	23155-962	23155-0962-0123155-0962-05
Acyclovir	Acyclovir 200 mg/1	CapsuleOral	Florida Pharmaceutical Products, LLC	71921-146	71921-0146-01
Acyclovir	Acyclovir 200 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7519	00904-7519-61
Acyclovir	Acyclovir 800 mg/1	TabletOral	Aurobindo Pharma Limited	59651-966	59651-0966-0159651-0966-0559651-0966-10
Acyclovir	Acyclovir 400 mg/1	TabletOral	Aurobindo Pharma Limited	59651-965	59651-0965-0159651-0965-0559651-0965-10
Acyclovir	Acyclovir 800 mg/1	TabletOral	REMEDYREPACK INC.	70518-4450	70518-4450-0070518-4450-01

All 194 acyclovir NDCs

Other NDCs under ANDA 206535

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

FDA NDC Directory listings under ANDA 206535
Product	Strength	Form · route	Labeler	Product NDC
acyclovir	Acyclovir sodium 50 mg/mL	Injection, SolutionIntravenous	Zydus Pharmaceuticals (USA) Inc.	68382-048
acyclovir	Acyclovir sodium 50 mg/mL	Injection, SolutionIntravenous	Zydus Lifesciences Limited	70771-1383
acyclovir	Acyclovir sodium 50 mg/mL	Injection, SolutionIntravenous	Zydus Lifesciences Limited	70771-1384