Prescription drug · ANDA

Diltiazem Hydrochloride NDC 46708-729

Diltiazem hydrochloride 360 mg/1 · Capsule, Extended release · Oral · Alembic Pharmaceuticals Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)46708-729Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46708-0729Add 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
46708-729-304670807293030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-729-30)Marketed from Nov 14, 2024
46708-729-904670807299090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-729-90)Marketed from Nov 14, 2024
46708-729-91467080729911000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-729-91)Marketed from Nov 14, 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 — 360 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216968
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers
Product ID 46708-729_063fdd2a-2532-45c6-8bb1-318064ff77bfSPL ID 063fdd2a-2532-45c6-8bb1-318064ff77bfSPL set ID d9c5c1ed-1a9d-494c-b798-9da09ba1fe1bRxCUI 830795, 830801, 830837, 830845, 830861UNII OLH94387TEUPC 0346708728304, 0346708726300, 0346708725303, 0346708729301, 0346708727307
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

N446708072930 followed by a unit qualifier and the quantity

Package 46708-0729-30. 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 216968

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

FDA NDC Directory listings under ANDA 216968
ProductStrengthForm · routeLabelerProduct NDC
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralAlembic Pharmaceuticals Inc.62332-725
Diltiazem HydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralAlembic Pharmaceuticals Inc.62332-726
Diltiazem HydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralAlembic Pharmaceuticals Inc.62332-727
Diltiazem HydrochlorideDiltiazem hydrochloride 300 mg/1Capsule, Extended releaseOralAlembic Pharmaceuticals Inc.62332-728
Diltiazem HydrochlorideDiltiazem hydrochloride 360 mg/1Capsule, Extended releaseOralAlembic Pharmaceuticals Inc.62332-729
Diltiazem HydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralAlembic Pharmaceuticals Limited46708-726
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralAlembic Pharmaceuticals Limited46708-725
Diltiazem HydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralAlembic Pharmaceuticals Limited46708-727
Diltiazem HydrochlorideDiltiazem hydrochloride 300 mg/1Capsule, Extended releaseOralAlembic Pharmaceuticals Limited46708-728

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Diltiazem Hydrochloride NDC 46708-729 | Med-Code