Amlodipine, Valsartan, Hydrochlorothiazide NDC 64380-198

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-198Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0198Add 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
64380-198-01	64380019801	30 TABLET, FILM COATED in 1 BOTTLE (64380-198-01)Marketed from Jun 27, 2022
64380-198-02	64380019802	90 TABLET, FILM COATED in 1 BOTTLE (64380-198-02)Marketed from Jun 27, 2022
64380-198-03	64380019803	500 TABLET, FILM COATED in 1 BOTTLE (64380-198-03)Marketed from Jun 27, 2022

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): Amlodipine, Valsartan, Hydrochlorothiazide
Generic name (nonproprietary): amlodipine besylate valsartan hydrochlorothiazide
Active ingredients: Amlodipine besylate — 5 mg/1Valsartan — 160 mg/1Hydrochlorothiazide — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Strides Pharma Science Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201087
Marketing start: Jun 27, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 64380-198_6c98cab6-e7ba-42ba-adf9-71fa67c0a403SPL ID 6c98cab6-e7ba-42ba-adf9-71fa67c0a403SPL set ID 9b76e441-e6a5-4036-8276-b7788ade5c44RxCUI 848131, 848135, 848140, 848145, 848151UNII 864V2Q084H, 0J48LPH2TH, 80M03YXJ7IUPC 0364380197010, 0364380199014, 0364380200017, 0364380201014
Pharmacologic class: Angiotensin 2 Receptor Blocker; Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker; Thiazide Diuretic

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

N464380019801 followed by a unit qualifier and the quantity

Package 64380-0198-01. 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 Apr 10, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Amlodipine/valsartan/hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine/valsartan/hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, l…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201087

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

FDA NDC Directory listings under ANDA 201087
Product	Strength	Form · route	Labeler	Product NDC
Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide	Amlodipine besylate 10 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-672
Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide	Amlodipine besylate 5 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-669
Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide	Amlodipine besylate 10 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-670
Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide	Amlodipine besylate 10 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-671
Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide	Amlodipine besylate 10 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Strides Pharma Science Limited	64380-199
Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide	Amlodipine besylate 5 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Strides Pharma Science Limited	64380-197
Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide	Amlodipine besylate 10 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Strides Pharma Science Limited	64380-200
Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide	Amlodipine besylate 10 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Strides Pharma Science Limited	64380-201
Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide	Amlodipine besylate 5 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-668