What is NDC 54348-624?

54348-624 is the product NDC for Acyclovir, Acyclovir 800 mg/1 tablet, listed with the FDA by PharmPak, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

PharmPak, Inc., NDC labeler code 54348. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Acyclovir NDC 54348-624 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)54348-624Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54348-0624Add 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
54348-624-10	54348062410	1 BOTTLE in 1 BOX (54348-624-10) / 10 TABLET in 1 BOTTLEMarketed from Jul 9, 2019

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: PharmPak, Inc.NDC labeler code 54348
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203834
Marketing start: Jul 9, 2019
Listing expires: Dec 31, 2026
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 54348-624_ea935f93-6c2c-2e8a-e053-2995a90a2ce0SPL ID ea935f93-6c2c-2e8a-e053-2995a90a2ce0SPL set ID d824fc07-9f03-4cb2-9bf8-ff7cc2955255RxCUI 197313UNII X4HES1O11F
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

N454348062410 followed by a unit qualifier and the quantity

Package 54348-0624-10. 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 Oct 9, 2022.

Indications (excerpt from the label)

INDICATIONS & USAGE Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets, USP 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 54348-624

What is NDC 54348-624?: 54348-624 is the product NDC for Acyclovir, Acyclovir 800 mg/1 tablet, listed with the FDA by PharmPak, 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?: PharmPak, Inc., NDC labeler code 54348. 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
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 400 mg/1	TabletOral	Aurobindo Pharma Limited	59651-965	59651-0965-0159651-0965-0559651-0965-10
Acyclovir	Acyclovir 800 mg/1	TabletOral	Aurobindo Pharma Limited	59651-966	59651-0966-0159651-0966-0559651-0966-10
Acyclovir	Acyclovir 800 mg/1	TabletOral	REMEDYREPACK INC.	70518-4450	70518-4450-0070518-4450-01

All 195 Acyclovir NDCs

Other NDCs under ANDA 203834

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

FDA NDC Directory listings under ANDA 203834
Product	Strength	Form · route	Labeler	Product NDC
Acyclovir	Acyclovir 400 mg/1	TabletOral	Major Pharmaceuticals	0904-7507
Acyclovir	Acyclovir 400 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-777
Acyclovir	Acyclovir 800 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-778
Acyclovir	Acyclovir 800 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-589
Acyclovir	Acyclovir 400 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-928
Acyclovir	Acyclovir 400 mg/1	TabletOral	A-S Medication Solutions	50090-6844
Acyclovir	Acyclovir 400 mg/1	TabletOral	Northwind Health Company, LLC	51655-300
Acyclovir	Acyclovir 800 mg/1	TabletOral	Northwind Health Company, LLC	51655-679
Acyclovir	Acyclovir 400 mg/1	TabletOral	PharmPak, Inc.	54348-627
Acyclovir	Acyclovir 800 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-778
Acyclovir	Acyclovir 400 mg/1	TabletOral	Proficient Rx LP	63187-253
Acyclovir	Acyclovir 800 mg/1	TabletOral	Proficient Rx LP	63187-574
Acyclovir	Acyclovir 400 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-1841
Acyclovir	Acyclovir 800 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3222
Acyclovir	Acyclovir 400 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4799
Acyclovir	Acyclovir 800 mg/1	TabletOral	Preferred Pharmaceuticals, Inc.	68788-7575
Acyclovir	Acyclovir 400 mg/1	TabletOral	REMEDYREPACK INC.	70518-2117
Acyclovir	Acyclovir 400 mg/1	TabletOral	REMEDYREPACK INC.	70518-2455
Acyclovir	Acyclovir 800 mg/1	TabletOral	REMEDYREPACK INC.	70518-2518
Acyclovir	Acyclovir 400 mg/1	TabletOral	Bryant Ranch Prepack	71335-0323

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