What is NDC 46708-186?

46708-186 is the product NDC for Telmisartan and Amlodipine, Telmisartan 80 mg/1; Amlodipine besylate 5 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Telmisartan, Amlodipine besylate.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 46708-186

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-186Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0186Add 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
46708-186-06	4670801860646708018606	60 BLISTER PACK in 1 CARTON (46708-186-06) / 6 TABLET in 1 BLISTER PACKMarketed from Nov 22, 2016

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): 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: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205234
Marketing start: Nov 22, 2016
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 46708-186_f0d9160e-9405-435e-9f36-75c537267221SPL ID f0d9160e-9405-435e-9f36-75c537267221SPL set ID 15b438b4-4874-43f4-a50a-4e6f3e5530acRxCUI 876514, 876519, 876524, 876529UNII U5SYW473RQ, 864V2Q084HUPC 0346708185084, 0346708187064, 0346708184087, 0346708186067
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

N446708018606 followed by a unit qualifier and the quantity

Package 46708-0186-06. 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 30, 2023. 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 46708-186

What is NDC 46708-186?: 46708-186 is the product NDC for Telmisartan and Amlodipine, Telmisartan 80 mg/1; Amlodipine besylate 5 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 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	—
Telmisartan and Amlodipine	Telmisartan 40 mg/1; Amlodipine besylate 10 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-197	—

Other NDCs under ANDA 205234

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

FDA NDC Directory listings under ANDA 205234
Product	Strength	Form · route	Labeler	Product NDC
Telmisartan and Amlodipine	Telmisartan 40 mg/1; Amlodipine besylate 5 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-184
Telmisartan and Amlodipine	Telmisartan 40 mg/1; Amlodipine besylate 10 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-185
Telmisartan and Amlodipine	Telmisartan 80 mg/1; Amlodipine besylate 10 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-187