What is NDC 43598-356?

43598-356 is the product NDC for valganciclovir hydrochloride, Valganciclovir hydrochloride 450 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

Dr. Reddy's Laboratories Inc, NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for valganciclovir hydrochloride?

6 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

valganciclovir hydrochloride NDC 43598-356

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-356Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0356Add 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
43598-356-30	4359803563043598035630	30 TABLET in 1 BOTTLE (43598-356-30)Marketed from Dec 12, 2017
43598-356-60	4359803566043598035660	60 TABLET in 1 BOTTLE (43598-356-60)Marketed from Dec 12, 2017

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): valganciclovir hydrochloride
Generic name (nonproprietary): valganciclovir hydrochloride
Active ingredients: Valganciclovir hydrochloride — 450 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Dr. Reddy's Laboratories IncNDC labeler code 43598
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206876
Marketing start: Dec 12, 2017
Listing expires: Dec 31, 2027
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 43598-356_2fbdd00d-733b-49f9-70b4-c1aefa75d6a4SPL ID 2fbdd00d-733b-49f9-70b4-c1aefa75d6a4SPL set ID e30ae2b2-dad2-39ba-6bc7-400807791ab0RxCUI 313566UNII 4P3T9QF9NZ
Pharmacologic class: Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor; Nucleoside Analog Antiviral

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

N443598035630 followed by a unit qualifier and the quantity

Package 43598-0356-30. 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 Dec 23, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Valganciclovir tablet is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for: Adult Patients (1.1) Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk. Pediatric Patients (1.2) Prevention of CMV disease in kidney and heart transplant patients at high risk. 1.1 Adult Patients Treatment of Cytomegalovirus (CMV) Retinitis : Valganciclovir tablets are indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies ( 14.1 ) ]. Prevention of CMV Disease : Valganciclovir t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-356

What is NDC 43598-356?: 43598-356 is the product NDC for valganciclovir hydrochloride, Valganciclovir hydrochloride 450 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: valganciclovir hydrochloride.
What is the active ingredient?: Valganciclovir hydrochloride.
Who is the labeler?: Dr. Reddy's Laboratories Inc, NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for valganciclovir hydrochloride?: 6 other product NDCs are listed under this name. See all valganciclovir hydrochloride 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 valganciclovir hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Valganciclovir Hydrochloride	Valganciclovir hydrochloride 450 mg/1	TabletOral	NorthStar Rx LLC	72603-750	72603-0750-01
valganciclovir hydrochloride	Valganciclovir hydrochloride 50 mg/mL	For solutionOral	Novadoz Pharmaceuticals LLC	72205-019	72205-0019-01
Valganciclovir Hydrochloridevalganciclovir	Valganciclovir 50 mg/mL	For solutionOral	Somerset Therapeutics, LLC	70069-810	70069-0810-01
Valganciclovir Hydrochloridevalganciclovir	Valganciclovir 50 mg/mL	For solutionOral	Granules Pharmaceuticals Inc.	70010-051	70010-0051-40
Valganciclovir hydrochloride	Valganciclovir hydrochloride 50 mg/mL	Powder, For solutionOral	Ajanta Pharma USA Inc.	27241-159	27241-0159-19
Valganciclovir Hydrochloride	Valganciclovir hydrochloride 450 mg/1	TabletOral	Aurobindo Pharma Limited	65862-753	65862-0753-0165862-0753-0565862-0753-18+2 more