NDC codes

FDA NDC Directory
Product NDC (as listed)46708-610Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46708-0610Add 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 NDC11-digit (billing)PackageCopy
46708-610-304670806103030 TABLET in 1 BOTTLE (46708-610-30)Marketed from Jun 25, 2016
46708-610-91467080610911000 TABLET in 1 BOTTLE (46708-610-91)Marketed from Jun 25, 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
Generic name (nonproprietary)
telmisartan
Active ingredients
Telmisartan — 80 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 202130
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 46708-610_9d5f0653-75d0-4c6d-81e9-d34f2e62a714SPL ID 9d5f0653-75d0-4c6d-81e9-d34f2e62a714SPL set ID 4be6575f-ea8d-4cd8-a49d-3d1c93f2621aRxCUI 205304, 205305, 282755UNII U5SYW473RQ

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

N446708061030 followed by a unit qualifier and the quantity

Package 46708-0610-30. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Telmisartanis an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions(1.1) 1.1 Hypertension Telmisartan is indicated for the treatment of hypertension, 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 the class to which this drug principally belongs. Control of high blood press…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-610

What is NDC 46708-610?
46708-610 is the product NDC for Telmisartan, Telmisartan 80 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Telmisartan.
What is the active ingredient?
Telmisartan.
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?
79 other product NDCs are listed under this name. See all Telmisartan 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TelmisartanTelmisartan 20 mg/1TabletOralRedpharm Drug67296-228467296-2284-09
TelmisartanTelmisartan 20 mg/1TabletOralNorthStar RxLLC72603-83172603-0831-01
TelmisartanTelmisartan 40 mg/1TabletOralNorthStar RxLLC72603-83272603-0832-01
TelmisartanTelmisartan 80 mg/1TabletOralNorthStar RxLLC72603-83372603-0833-01
TelmisartanTelmisartan 40 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-403468788-4034-03
TelmisartanTelmisartan 20 mg/1TabletOralMacleods Pharmaceuticals Limited33342-11833342-0118-0733342-0118-10
TelmisartanTelmisartan 40 mg/1TabletOralMacleods Pharmaceuticals Limited33342-11933342-0119-0733342-0119-10
TelmisartanTelmisartan 80 mg/1TabletOralMacleods Pharmaceuticals Limited33342-12033342-0120-0733342-0120-10
TelmisartanTelmisartan 20 mg/1TabletOralLifestar Pharma LLC70756-31270756-0312-3070756-0312-99
TelmisartanTelmisartan 40 mg/1TabletOralLifestar Pharma LLC70756-31370756-0313-3070756-0313-80

All 80 Telmisartan NDCs

Other NDCs under ANDA 202130

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

FDA NDC Directory listings under ANDA 202130
ProductStrengthForm · routeLabelerProduct NDC
TelmisartanTelmisartan 20 mg/1TabletOralAlembic Pharmaceuticals Limited46708-608
TelmisartanTelmisartan 40 mg/1TabletOralAlembic Pharmaceuticals Limited46708-609
TelmisartanTelmisartan 20 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-087
TelmisartanTelmisartan 40 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-088
TelmisartanTelmisartan 80 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-089

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