Prescription drug · ANDA

Diltiazem Hydrochloride NDC 62135-333

Diltiazem hydrochloride 30 mg/1 · Tablet · Oral · Chartwell RX, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)62135-333Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0333Add 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
62135-333-1262135033312120 TABLET in 1 BOTTLE (62135-333-12)Marketed from Jun 17, 2024

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)
Diltiazem Hydrochloride
Generic name (nonproprietary)
diltiazem hydrochloride
Active ingredients
Diltiazem hydrochloride — 30 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074093
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers
Product ID 62135-333_1b432d9d-b46c-2ee8-e063-6294a90adb54SPL ID 1b432d9d-b46c-2ee8-e063-6294a90adb54SPL set ID 51abce7b-e3d1-44b5-bccc-d463150d0bbaRxCUI 831054, 831102, 831103, 833217UNII OLH94387TEUPC 0362135334123, 0362135336905, 0362135335908, 0362135333126
Pharmacologic class
Calcium Channel Blocker

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

N462135033312 followed by a unit qualifier and the quantity

Package 62135-0333-12. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Diltiazem hydrochloride is indicated for the management of chronic stable angina and angina due to coronary artery spasm.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 074093

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

FDA NDC Directory listings under ANDA 074093
ProductStrengthForm · routeLabelerProduct NDC
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1TabletOralChartwell RX, LLC62135-336
Diltiazem HydrochlorideDiltiazem hydrochloride 60 mg/1TabletOralChartwell RX, LLC62135-334
Diltiazem HydrochlorideDiltiazem hydrochloride 90 mg/1TabletOralChartwell RX, LLC62135-335

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Diltiazem Hydrochloride NDC 62135-333 | Med-Code