What is NDC 33342-281?

33342-281 is the product NDC for amlodipine and valsartan, Amlodipine besylate 5 mg/1; Valsartan 320 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Amlodipine besylate, Valsartan.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for amlodipine and valsartan?

35 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

amlodipine and valsartan NDC 33342-281

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-281Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0281Add 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
33342-281-07	3334202810733342028107	30 TABLET in 1 BOTTLE (33342-281-07)Marketed from Oct 16, 2024
33342-281-10	3334202811033342028110	90 TABLET in 1 BOTTLE (33342-281-10)Marketed from Oct 16, 2024
33342-281-12	3334202811233342028112	10 BLISTER PACK in 1 CARTON (33342-281-12) / 10 TABLET in 1 BLISTER PACKMarketed from Oct 16, 2024

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 and valsartan
Generic name (nonproprietary): amlodipine and valsartan
Active ingredients: Amlodipine besylate — 5 mg/1Valsartan — 320 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207292
Marketing start: Oct 16, 2024
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)
Identifiers: Product ID 33342-281_d520c66f-440c-4f7e-b057-0d548c3142e7SPL ID d520c66f-440c-4f7e-b057-0d548c3142e7SPL set ID 5dfadaf0-c333-4b79-9a97-e42f77505c40RxCUI 722126, 722131, 722134, 722137UNII 80M03YXJ7I, 864V2Q084HUPC 0333342280107, 0333342282101, 0333342279071, 0333342281104, 0333342281074, 0333342282071, 0333342279101
Pharmacologic class: Angiotensin 2 Receptor Blocker; Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker

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

N433342028107 followed by a unit qualifier and the quantity

Package 33342-0281-07. 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 Dec 30, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Amlodipine and valsartan tablets, USP are the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets, USP are indicated for the treatment of hypertension, to lower blood pressure: • In patients not adequately controlled on monotherapy ( 1 ) • As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals ( 1 ). Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 1.1 Hypertension Amlodipine and valsartan tablets, USP are indicated for the treatment of hyperte…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-281

What is NDC 33342-281?: 33342-281 is the product NDC for amlodipine and valsartan, Amlodipine besylate 5 mg/1; Valsartan 320 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: amlodipine and valsartan.
What is the active ingredient?: Amlodipine besylate, Valsartan.
Who is the labeler?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for amlodipine and valsartan?: 35 other product NDCs are listed under this name. See all amlodipine and valsartan 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 amlodipine and valsartan NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
amlodipine and valsartan	Amlodipine besylate 5 mg/1; Valsartan 160 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-279	33342-0279-0733342-0279-1033342-0279-12
amlodipine and valsartan	Amlodipine besylate 10 mg/1; Valsartan 160 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-280	33342-0280-0733342-0280-1033342-0280-12
amlodipine and valsartan	Amlodipine besylate 10 mg/1; Valsartan 320 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-282	33342-0282-0733342-0282-1033342-0282-12
Amlodipine and Valsartan	Amlodipine 5 mg/1; Valsartan 160 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-844	23155-0844-0323155-0844-09
Amlodipine and Valsartan	Amlodipine 10 mg/1; Valsartan 160 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-845	23155-0845-0323155-0845-09
Amlodipine and Valsartan	Amlodipine 5 mg/1; Valsartan 320 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-846	23155-0846-0323155-0846-09
Amlodipine and Valsartan	Amlodipine 10 mg/1; Valsartan 320 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-847	23155-0847-0323155-0847-09
Amlodipine and Valsartan	Amlodipine besylate 5 mg/1; Valsartan 160 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-458	46708-0458-1046708-0458-3046708-0458-31+2 more
Amlodipine and Valsartan	Amlodipine besylate 10 mg/1; Valsartan 160 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-459	46708-0459-1046708-0459-3046708-0459-31+2 more
Amlodipine and Valsartan	Amlodipine besylate 5 mg/1; Valsartan 320 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-460	46708-0460-1046708-0460-3046708-0460-31+2 more

All 36 amlodipine and valsartan NDCs

Other NDCs under ANDA 207292

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

FDA NDC Directory listings under ANDA 207292
Product	Strength	Form · route	Labeler	Product NDC
amlodipine and valsartan	Amlodipine besylate 5 mg/1; Valsartan 160 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-279
amlodipine and valsartan	Amlodipine besylate 10 mg/1; Valsartan 160 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-280
amlodipine and valsartan	Amlodipine besylate 10 mg/1; Valsartan 320 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-282