What is NDC 68180-197?

68180-197 is the product NDC for Telmisartan and Amlodipine, Telmisartan 40 mg/1; Amlodipine besylate 10 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals, Inc..

What is the active ingredient?

Telmisartan, Amlodipine besylate.

Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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 68180-197

NDC codes

FDA NDC Directory

Product NDC (as listed)68180-197Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68180-0197Add the package segment from the table below.

Product information

Brand name (proprietary): Telmisartan and Amlodipine
Generic name (nonproprietary): telmisartan and amlodipine
Active ingredients: Telmisartan — 40 mg/1Amlodipine besylate — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Lupin Pharmaceuticals, Inc.NDC labeler code 68180
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201586
Marketing start: Jan 8, 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 68180-197_17a6182b-5050-470e-aa1d-1605fa9e088eSPL ID 17a6182b-5050-470e-aa1d-1605fa9e088eSPL set ID a97fefa6-99e6-4eb7-9393-ab2252a2c7d8RxCUI 876514, 876519, 876524, 876529UNII U5SYW473RQ, 864V2Q084HUPC 0368180196068
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.

Product label

Current FDA label (SPL), effective Dec 15, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Telmisartan and amlodipine tablet is an angiotensin II receptor blocker (ARB) and a dihydropyridine calcium channel blocker (DHP-CCB) combination product 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. ( 1 ) Telmisartan and amlodipine tablets are indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals ( 1 ) Telmisartan and amlodipine tablets are indicated for the treatment of hypertension, alone or with other antihypertensive ag…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68180-197

What is NDC 68180-197?: 68180-197 is the product NDC for Telmisartan and Amlodipine, Telmisartan 40 mg/1; Amlodipine besylate 10 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals, Inc..
What drug is associated with this NDC?: Telmisartan and Amlodipine.
What is the active ingredient?: Telmisartan, Amlodipine besylate.
Who is the labeler?: Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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 5 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-1077	00378-1077-93
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	—

Other NDCs under ANDA 201586

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

FDA NDC Directory listings under ANDA 201586
Product	Strength	Form · route	Labeler	Product NDC
Telmisartan and Amlodipine	Telmisartan 40 mg/1; Amlodipine besylate 5 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-196