NDC codes

FDA NDC Directory
Product NDC (as listed)63629-5682Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-5682Add 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
63629-5682-16362956820130 TABLET in 1 BOTTLE (63629-5682-1)Marketed from Jan 14, 2021
63629-5682-26362956820290 TABLET in 1 BOTTLE (63629-5682-2)Marketed from Mar 9, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 40 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205150
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers
Product ID 63629-5682_33603cf2-4536-8522-e063-6394a90a379fSPL ID 33603cf2-4536-8522-e063-6394a90a379fSPL set ID 44e810d4-cf04-41d3-bdf8-0681210a669fRxCUI 205304UNII 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

N463629568201 followed by a unit qualifier and the quantity

Package 63629-5682-01. 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)

Telmisartan tablets, USP are 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 ) Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors ( 1.2 ) 1.1 Hypertension Telmisartan tablets, USP are 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 v…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-5682

What is NDC 63629-5682?
63629-5682 is the product NDC for telmisartan, Telmisartan 40 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. 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?
Bryant Ranch Prepack, NDC labeler code 63629. 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 205150

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

FDA NDC Directory listings under ANDA 205150
ProductStrengthForm · routeLabelerProduct NDC
telmisartanTelmisartan 80 mg/1TabletOralProficient Rx LP63187-951
telmisartanTelmisartan 20 mg/1TabletOralAscend Laboratories, LLC67877-482
telmisartanTelmisartan 40 mg/1TabletOralAscend Laboratories, LLC67877-483
telmisartanTelmisartan 80 mg/1TabletOralAscend Laboratories, LLC67877-484
telmisartanTelmisartan 40 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8440
telmisartanTelmisartan 20 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8441
telmisartanTelmisartan 80 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8718
telmisartanTelmisartan 80 mg/1TabletOralREMEDYREPACK INC.70518-3798
telmisartanTelmisartan 80 mg/1TabletOralBryant Ranch Prepack71335-1428
telmisartanTelmisartan 20 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-371

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