What is NDC 0378-1724?

0378-1724 is the product NDC for Amlodipine And Valsartan, Amlodipine besylate 10 mg/1; Valsartan 320 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Amlodipine besylate, Valsartan.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 0378-1724

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-1724Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-1724Add 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
0378-1724-93	0037817249300378172493	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1724-93)Marketed from Mar 30, 2015

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 mg/1Valsartan — 320 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090483
Marketing start: Mar 30, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 0378-1724_97bfe7c1-7e4b-45a1-b045-ff48275f1488SPL ID 97bfe7c1-7e4b-45a1-b045-ff48275f1488SPL set ID aa7e7d95-520a-461c-b1b3-e588aeb6a613RxCUI 722126, 722131, 722134, 722137UNII 80M03YXJ7I, 864V2Q084HUPC 0303781722933, 0303781723930, 0303781721936, 0303781724937
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

N400378172493 followed by a unit qualifier and the quantity

Package 00378-1724-93. 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 Aug 31, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

Amlodipine and valsartan is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets 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 are indicated for the treatment of hypertension, to lower blood pre…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-1724

What is NDC 0378-1724?: 0378-1724 is the product NDC for Amlodipine And Valsartan, Amlodipine besylate 10 mg/1; Valsartan 320 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 5 mg/1; Valsartan 320 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-281	33342-0281-0733342-0281-1033342-0281-12
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

All 36 Amlodipine And Valsartan NDCs

Other NDCs under ANDA 090483

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

FDA NDC Directory listings under ANDA 090483
Product	Strength	Form · route	Labeler	Product NDC
Amlodipine And Valsartan	Amlodipine besylate 5 mg/1; Valsartan 160 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-1721
Amlodipine And Valsartan	Amlodipine besylate 10 mg/1; Valsartan 160 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-1722
Amlodipine And Valsartan	Amlodipine besylate 5 mg/1; Valsartan 320 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-1723