Prescription drug · ANDA

diltiazem hydrochloride NDC 0615-8380

Diltiazem hydrochloride 180 mg/1 · Capsule, Extended release · Oral · NCS HealthCare of KY, LLC dba Vangard Labs

NDC codes

FDA NDC Directory
Product NDC (as listed)0615-8380Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00615-8380Add 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
0615-8380-390061583803930 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8380-39)Marketed from Feb 10, 2021

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 180 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208783
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers
Product ID 0615-8380_72f92a1f-d8d6-494e-a8e9-875ca4bf4b50SPL ID 72f92a1f-d8d6-494e-a8e9-875ca4bf4b50SPL set ID 70f167a1-ec7f-4969-b446-166af3e52c05RxCUI 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

N400615838039 followed by a unit qualifier and the quantity

Package 00615-8380-39. 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 208783

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

FDA NDC Directory listings under ANDA 208783
ProductStrengthForm · routeLabelerProduct NDC
diltiazem hydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralPreferred Pharmaceuticals Inc.68788-7870
diltiazem hydrochlorideDiltiazem hydrochloride 360 mg/1Capsule, Extended releaseOralIngenus Pharmaceuticals, LLC50742-252
diltiazem hydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralIngenus Pharmaceuticals, LLC50742-249
diltiazem hydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralIngenus Pharmaceuticals, LLC50742-250
diltiazem hydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-2602
diltiazem hydrochlorideDiltiazem hydrochloride 300 mg/1Capsule, Extended releaseOralIngenus Pharmaceuticals, LLC50742-251
diltiazem hydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-1776
diltiazem hydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-3091
Diltiazem HCL ERDiltiazem hydrochloride 300 mg/1Capsule, Extended releaseOralDirect_Rx72189-409
diltiazem hydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-2089
diltiazem hydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralIngenus Pharmaceuticals, LLC50742-248
diltiazem hydrochlorideDiltiazem hydrochloride 360 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-1897
diltiazem hydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8379
diltiazem hydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8381
diltiazem hydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralGolden State Medical Supply, Inc.84677-040
diltiazem hydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralGolden State Medical Supply, Inc.84677-039
diltiazem hydrochlorideDiltiazem hydrochloride 300 mg/1Capsule, Extended releaseOralGolden State Medical Supply, Inc.84677-042
diltiazem hydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralGolden State Medical Supply, Inc.84677-041
diltiazem hydrochlorideDiltiazem hydrochloride 360 mg/1Capsule, Extended releaseOralGolden State Medical Supply, Inc.84677-043
diltiazem hydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-3484

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