NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8440Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8440Add 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
68788-8440-36878884400330 TABLET in 1 BOTTLE (68788-8440-3)Marketed from May 2, 2023
68788-8440-66878884400660 TABLET in 1 BOTTLE (68788-8440-6)Marketed from May 2, 2023
68788-8440-96878884400990 TABLET in 1 BOTTLE (68788-8440-9)Marketed from May 2, 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
Preferred Pharmaceuticals Inc.NDC labeler code 68788
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 68788-8440_610f65b7-7830-4699-a117-2f37d248006aSPL ID 610f65b7-7830-4699-a117-2f37d248006a

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

N468788844003 followed by a unit qualifier and the quantity

Package 68788-8440-03. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 68788-8440

What is NDC 68788-8440?
68788-8440 is the product NDC for telmisartan, Telmisartan 40 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 3 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 40 mg/1TabletOralBryant Ranch Prepack63629-5682
telmisartanTelmisartan 20 mg/1TabletOralAscend Laboratories, LLC67877-482
telmisartanTelmisartan 40 mg/1TabletOralAscend Laboratories, LLC67877-483
telmisartanTelmisartan 80 mg/1TabletOralAscend Laboratories, LLC67877-484
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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