NDC codes

FDA NDC Directory
Product NDC (as listed)68462-329Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68462-0329Add 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
68462-329-016846203290168462032901100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-329-01)Marketed from Feb 25, 2015
68462-329-1068462032910684620329101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-329-10)Marketed from Feb 25, 2015

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

Generic name (nonproprietary)
trandolapril and verapamil hydrochloride
Active ingredients
Trandolapril — 4 mg/1Verapamil hydrochloride — 240 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079135
Marketing start
Listing expires
Other FDA classes
Angiotensin-converting Enzyme Inhibitors (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers
Product ID 68462-329_770b4914-a475-4841-83f8-79261f115effSPL ID 770b4914-a475-4841-83f8-79261f115effSPL set ID 39bad727-af4c-4d20-933b-7f287e88099aRxCUI 897781, 897783, 897844, 897853UNII V3888OEY5R, 1T0N3G9CRCUPC 0368462294017, 0368462329016

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

N468462032901 followed by a unit qualifier and the quantity

Package 68462-0329-01. 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)

INDICATIONS AND USAGE Trandolapril and verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION ). In using trandolapril and verapamil hydrochloride extended-release tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that trandolapril does not have similar risk (see WARNINGS - Neutropenia/Agranulocytosis ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-329

What is NDC 68462-329?
68462-329 is the product NDC for Trandolapril and Verapamil Hydrochloride, Trandolapril 4 mg/1; Verapamil hydrochloride 240 mg/1 tablet, film coated, extended release, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Trandolapril and Verapamil Hydrochloride.
What is the active ingredient?
Trandolapril, Verapamil hydrochloride.
Who is the labeler?
Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Trandolapril and Verapamil Hydrochloride?
3 other product NDCs are listed under this name. See all Trandolapril and Verapamil Hydrochloride 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 Trandolapril and Verapamil Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Trandolapril and Verapamil HydrochlorideTrandolapril 1 mg/1; Verapamil hydrochloride 240 mg/1Tablet, Film coated, Extended releaseOralGlenmark Pharmaceuticals Inc., USA68462-29468462-0294-0168462-0294-1068462-0294-90
Trandolapril and Verapamil HydrochlorideTrandolapril 2 mg/1; Verapamil hydrochloride 180 mg/1Tablet, Film coated, Extended releaseOralGlenmark Pharmaceuticals Inc., USA68462-29568462-0295-0168462-0295-1068462-0295-90
Trandolapril and Verapamil HydrochlorideTrandolapril 2 mg/1; Verapamil hydrochloride 240 mg/1Tablet, Film coated, Extended releaseOralGlenmark Pharmaceuticals Inc., USA68462-29668462-0296-0168462-0296-1068462-0296-90

Other NDCs under ANDA 079135

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

FDA NDC Directory listings under ANDA 079135
ProductStrengthForm · routeLabelerProduct NDC
Trandolapril and Verapamil HydrochlorideTrandolapril 1 mg/1; Verapamil hydrochloride 240 mg/1Tablet, Film coated, Extended releaseOralGlenmark Pharmaceuticals Inc., USA68462-294
Trandolapril and Verapamil HydrochlorideTrandolapril 2 mg/1; Verapamil hydrochloride 180 mg/1Tablet, Film coated, Extended releaseOralGlenmark Pharmaceuticals Inc., USA68462-295
Trandolapril and Verapamil HydrochlorideTrandolapril 2 mg/1; Verapamil hydrochloride 240 mg/1Tablet, Film coated, Extended releaseOralGlenmark Pharmaceuticals Inc., USA68462-296

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