What is NDC 0378-1077?

0378-1077 is the product NDC for Telmisartan and Amlodipine, Telmisartan 80 mg/1; Amlodipine besylate 5 mg/1 tablet, 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?

Telmisartan, Amlodipine besylate.

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 Telmisartan and Amlodipine?

9 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Telmisartan and Amlodipine NDC 0378-1077

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-1077Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-1077Add 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
0378-1077-93	0037810779300378107793	30 TABLET in 1 BOTTLE, PLASTIC (0378-1077-93)Marketed from Sep 19, 2014

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): Telmisartan and Amlodipine
Generic name (nonproprietary): telmisartan and amlodipine
Active ingredients: Telmisartan — 80 mg/1Amlodipine besylate — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202516
Marketing start: Sep 19, 2014
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 0378-1077_c4f4323d-671d-478b-b088-008530932ceeSPL ID c4f4323d-671d-478b-b088-008530932ceeSPL set ID ca60a4d5-ace7-4889-94ee-e2265fd63811RxCUI 876514, 876519, 876524, 876529UNII U5SYW473RQ, 864V2Q084HUPC 0303781075930, 0303781076937, 0303781078931, 0303781077934
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

N400378107793 followed by a unit qualifier and the quantity

Package 00378-1077-93. 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 Nov 14, 2018. This label includes a boxed warning.

Indications (excerpt from the label)

Telmisartan and amlodipine tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents 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 angiotensin II receptor blockers and dihydropyridine calcium channel blockers. There are no controlled trials demonstrating risk reduction with telmisartan and amlodipine tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, includin…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-1077

What is NDC 0378-1077?: 0378-1077 is the product NDC for Telmisartan and Amlodipine, Telmisartan 80 mg/1; Amlodipine besylate 5 mg/1 tablet, 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?: Telmisartan and Amlodipine.
What is the active ingredient?: Telmisartan, Amlodipine besylate.
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 Telmisartan and Amlodipine?: 9 other product NDCs are listed under this name. See all Telmisartan and Amlodipine 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 Telmisartan and Amlodipine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Telmisartan and Amlodipine	Telmisartan 40 mg/1; Amlodipine besylate 5 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-184	46708-0184-08
Telmisartan and Amlodipine	Telmisartan 40 mg/1; Amlodipine besylate 10 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-185	46708-0185-08
Telmisartan and Amlodipine	Telmisartan 80 mg/1; Amlodipine besylate 5 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-186	46708-0186-06
Telmisartan and Amlodipine	Telmisartan 80 mg/1; Amlodipine besylate 10 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-187	46708-0187-06
Telmisartan and Amlodipine	Telmisartan 40 mg/1; Amlodipine besylate 5 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-1075	00378-1075-93
Telmisartan and Amlodipine	Telmisartan 40 mg/1; Amlodipine besylate 10 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-1076	00378-1076-93
Telmisartan and Amlodipine	Telmisartan 80 mg/1; Amlodipine besylate 10 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-1078	00378-1078-93
Telmisartan and Amlodipine	Telmisartan 40 mg/1; Amlodipine besylate 5 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-196	—
Telmisartan and Amlodipine	Telmisartan 40 mg/1; Amlodipine besylate 10 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-197	—

Other NDCs under ANDA 202516

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

FDA NDC Directory listings under ANDA 202516
Product	Strength	Form · route	Labeler	Product NDC
Telmisartan and Amlodipine	Telmisartan 40 mg/1; Amlodipine besylate 5 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-1075
Telmisartan and Amlodipine	Telmisartan 40 mg/1; Amlodipine besylate 10 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-1076
Telmisartan and Amlodipine	Telmisartan 80 mg/1; Amlodipine besylate 10 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-1078