What is NDC 49483-691?

49483-691 is the product NDC for Valacyclovir Hydrochloride, Valacyclovir hydrochloride 1 g/1 tablet, listed with the FDA by TIME CAP LABORATORIES, INC.. It has 4 package NDCs, shown above in 10- and 11-digit form.

TIME CAP LABORATORIES, INC., NDC labeler code 49483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Valacyclovir Hydrochloride?

56 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Valacyclovir Hydrochloride NDC 49483-691

NDC codes

FDA NDC Directory

Product NDC (as listed)49483-691Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49483-0691Add 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
49483-691-01	49483069101	100 TABLET in 1 BOTTLE (49483-691-01)Marketed from Jul 14, 2021
49483-691-03	49483069103	30 TABLET in 1 BOTTLE (49483-691-03)Marketed from Jul 14, 2021
49483-691-04	49483069104	10 TABLET in 1 BLISTER PACK (49483-691-04)Marketed from Jul 14, 2021
49483-691-50	49483069150	500 TABLET in 1 BOTTLE (49483-691-50)Marketed from Jul 14, 2021

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): Valacyclovir Hydrochloride
Generic name (nonproprietary): valacyclovir hydrochloride
Active ingredients: Valacyclovir hydrochloride — 1 g/1
Dosage form: Tablet
Route: Oral
Labeler: TIME CAP LABORATORIES, INC.NDC labeler code 49483
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079012
Marketing start: Jul 14, 2021
Listing expires: Dec 31, 2026
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 49483-691_c715d9f2-9fe1-0bdd-e053-2a95a90aecf2SPL ID c715d9f2-9fe1-0bdd-e053-2a95a90aecf2SPL set ID c33a2a36-16d3-4a35-e053-2995a90af240RxCUI 313564, 313565UNII G447S0T1VCUPC 0349483691047, 0349483691504, 0349483690040
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

N449483069101 followed by a unit qualifier and the quantity

Package 49483-0691-01. 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 Jul 17, 2021.

Indications (excerpt from the label)

Valacyclovir is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) • Cold Sores (Herpes Labialis) • Genital Herpes • Treatment in immunocompetent patients (initial or recurrent episode) • Suppression in immunocompetent or HIV-1-infected patients • Reduction of transmission • Herpes Zoster Pediatric Patients (1.2) • Cold Sores (Herpes Labialis) • Chickenpox Limitations of Use (1.3) The efficacy and safety of valacyclovir have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients. 1.1 Adult Patients Cold Sores (Herpes Labialis) Valacyclovir is indicated for treatment of cold sores (her…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 49483-691

What is NDC 49483-691?: 49483-691 is the product NDC for Valacyclovir Hydrochloride, Valacyclovir hydrochloride 1 g/1 tablet, listed with the FDA by TIME CAP LABORATORIES, INC.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Valacyclovir Hydrochloride.
What is the active ingredient?: Valacyclovir hydrochloride.
Who is the labeler?: TIME CAP LABORATORIES, INC., NDC labeler code 49483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Valacyclovir Hydrochloride?: 56 other product NDCs are listed under this name. See all Valacyclovir 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 Valacyclovir Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Valacyclovir Hydrochloridevalacyclovir	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	Northwind Health Company, LLC	82868-106	82868-0106-21
Valacyclovir Hydrochloridevalacyclovir	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-144	48433-0144-03
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8904	68788-8904-0368788-8904-09
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8820	68788-8820-0068788-8820-0168788-8820-02+4 more
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-757	60760-0757-42
Valacyclovir Hydrochloridevalacyclovir	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	82868-055	82868-0055-21
Valacyclovir Hydrochloridevalacyclovir	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8482	68788-8482-0368788-8482-09
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-703	51655-0703-0451655-0703-2151655-0703-53
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 500 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-633	51655-0633-2151655-0633-84
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 1 g/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3359	70518-3359-0170518-3359-0270518-3359-03

All 57 Valacyclovir Hydrochloride NDCs

Other NDCs under ANDA 079012

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

FDA NDC Directory listings under ANDA 079012
Product	Strength	Form · route	Labeler	Product NDC
Valacyclovir Hydrochloride	Valacyclovir hydrochloride 500 mg/1	TabletOral	TIME CAP LABORATORIES, INC.	49483-690