Prescription drug · ANDA

diltiazem hydrochloride NDC 68382-597

Diltiazem hydrochloride 240 mg/1 · Capsule, Extended release · Oral · Zydus Pharmaceuticals (USA) Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68382-597Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68382-0597Add 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
68382-597-0168382059701100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-597-01)Marketed from Sep 28, 2017
68382-597-0568382059705500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-597-05)Marketed from Oct 2, 2018
68382-597-066838205970630 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-597-06)Marketed from Sep 28, 2017
68382-597-166838205971690 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-597-16)Marketed from Sep 28, 2017
68382-597-776838205977710 BLISTER PACK in 1 CARTON (68382-597-77) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-597-30)Marketed from Sep 28, 2017

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 — 240 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206534
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers
Product ID 68382-597_3683dc39-602e-463a-b04a-6d066d2fe94dSPL ID 3683dc39-602e-463a-b04a-6d066d2fe94dSPL set ID 1e2f2025-0350-40c4-ab42-3b57f3d105a6RxCUI 830795, 830801, 830837, 830845, 830861UNII OLH94387TE
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

N468382059701 followed by a unit qualifier and the quantity

Package 68382-0597-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are 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 206534

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

FDA NDC Directory listings under ANDA 206534
ProductStrengthForm · routeLabelerProduct NDC
diltiazem hydrochlorideDiltiazem hydrochloride 300 mg/1Capsule, Extended releaseOralZydus Lifesciences Limited70771-1033
diltiazem hydrochlorideDiltiazem hydrochloride 360 mg/1Capsule, Extended releaseOralZydus Lifesciences Limited70771-1034
diltiazem hydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralZydus Lifesciences Limited70771-1032
diltiazem hydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralZydus Lifesciences Limited70771-1030
diltiazem hydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralZydus Lifesciences Limited70771-1031
diltiazem hydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals (USA) Inc.68382-596
diltiazem hydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals (USA) Inc.68382-595
diltiazem hydrochlorideDiltiazem hydrochloride 300 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals (USA) Inc.68382-598
diltiazem hydrochlorideDiltiazem hydrochloride 360 mg/1Capsule, Extended releaseOralZydus Pharmaceuticals (USA) Inc.68382-599
diltiazem hydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-9708

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in
diltiazem hydrochloride NDC 68382-597 | Med-Code