amlodipine,valsartan and hydrochlorothiazide NDC 33342-283

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-283Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0283Add 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
33342-283-07	33342028307	30 TABLET, FILM COATED in 1 BOTTLE (33342-283-07)Marketed from Jan 6, 2025
33342-283-10	33342028310	90 TABLET, FILM COATED in 1 BOTTLE (33342-283-10)Marketed from Jan 6, 2025
33342-283-12	33342028312	10 BLISTER PACK in 1 CARTON (33342-283-12) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 6, 2025

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 and hydrochlorothiazide
Generic name (nonproprietary): amlodipine,valsartan and hydrochlorothiazide
Active ingredients: Amlodipine besylate — 5 mg/1Valsartan — 160 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Macleods Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207299
Marketing start: Jan 6, 2025
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 33342-283_1ea4f227-b97a-49f1-bbc3-1dede2c1866dSPL ID 1ea4f227-b97a-49f1-bbc3-1dede2c1866dSPL set ID 1ea4f227-b97a-49f1-bbc3-1dede2c1866dRxCUI 848131, 848135, 848140, 848145, 848151UNII 80M03YXJ7I, 0J48LPH2TH, 864V2Q084HUPC 0333342283078, 0333342287076, 0333342284075
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

N433342028307 followed by a unit qualifier and the quantity

Package 33342-0283-07. 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 Jan 9, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Amlodipine, valsartan and hydrochlorothiazide tablets are 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 and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207299

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

FDA NDC Directory listings under ANDA 207299
Product	Strength	Form · route	Labeler	Product NDC
amlodipine,valsartan and hydrochlorothiazide	Amlodipine besylate 10 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-287
amlodipine,valsartan and hydrochlorothiazide	Amlodipine besylate 10 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-284
amlodipine,valsartan and hydrochlorothiazide	Amlodipine besylate 5 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-285
amlodipine,valsartan and hydrochlorothiazide	Amlodipine besylate 10 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-286