NDC codes

FDA NDC Directory
Product NDC (as listed)68180-193Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68180-0193Add the package segment from the table below.

Product information

Brand name (proprietary)
Telmisartan and Hydrochlorothiazide
Generic name (nonproprietary)
telmisartan and hydrochlorothiazide
Active ingredients
Hydrochlorothiazide — 12.5 mg/1Telmisartan — 40 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 091351
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers
Product ID 68180-193_92888a3c-daab-4cd1-b883-6ecbe682faa9SPL ID 92888a3c-daab-4cd1-b883-6ecbe682faa9SPL set ID b88054b3-fafa-4b4e-acf5-5294e5555720RxCUI 283316, 283317, 477130UNII 0J48LPH2TH, U5SYW473RQ
Pharmacologic class
Angiotensin 2 Receptor Blocker; Thiazide Diuretic

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 . This label includes a boxed warning.

Indications (excerpt from the label)

Telmisartan and hydrochlorothiazide tablets are combination of an angiotensin II receptor blocker (ARB) and a thiazide diuretic 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 hydrochlorothiazide tablets are not indicated for initial therapy ( 1 ) Telmisartan and hydrochlorothiazide tablets 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 myocar…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68180-193

What is NDC 68180-193?
68180-193 is the product NDC for Telmisartan and Hydrochlorothiazide, Hydrochlorothiazide 12.5 mg/1; Telmisartan 40 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals, Inc..
What drug is associated with this NDC?
Telmisartan and Hydrochlorothiazide.
What is the active ingredient?
Hydrochlorothiazide, Telmisartan.
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 Hydrochlorothiazide?
22 other product NDCs are listed under this name. See all Telmisartan and Hydrochlorothiazide 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 Hydrochlorothiazide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
telmisartan and hydrochlorothiazideTelmisartan 40 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralLifestar Pharma LLC70756-31570756-0315-3070756-0315-3170756-0315-99
telmisartan and hydrochlorothiazideTelmisartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralLifestar Pharma LLC70756-31670756-0316-3070756-0316-3170756-0316-99
telmisartan and hydrochlorothiazideTelmisartan 80 mg/1; Hydrochlorothiazide 25 mg/1TabletOralLifestar Pharma LLC70756-31770756-0317-3070756-0317-3170756-0317-99
Telmisartan and HydrochlorothiazideTelmisartan 40 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralAvKARE42291-46242291-0462-30
Telmisartan and HydrochlorothiazideTelmisartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralAvKARE42291-46342291-0463-30
Telmisartan and HydrochlorothiazideTelmisartan 80 mg/1; Hydrochlorothiazide 25 mg/1TabletOralAvKARE42291-46442291-0464-30
Telmisartan and HydrochlorothiazideTelmisartan 40 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-84068462-0840-13
Telmisartan and HydrochlorothiazideTelmisartan 80 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-84168462-0841-13
Telmisartan and HydrochlorothiazideTelmisartan 80 mg/1; Hydrochlorothiazide 25 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-84268462-0842-13
Telmisartan And HydrochlorothiazideTelmisartan 40 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralSolco Healthcare LLC43547-44143547-0441-0343547-0441-09

All 23 Telmisartan and Hydrochlorothiazide NDCs

Other NDCs under ANDA 091351

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

FDA NDC Directory listings under ANDA 091351
ProductStrengthForm · routeLabelerProduct NDC
Telmisartan and HydrochlorothiazideHydrochlorothiazide 12.5 mg/1; Telmisartan 80 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-194
Telmisartan and HydrochlorothiazideHydrochlorothiazide 25 mg/1; Telmisartan 80 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-195

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