Prescription drug · ANDA

Diltiazem Hydrochloride NDC 55154-4321

Diltiazem hydrochloride 180 mg/1 · Capsule, Extended release · Oral · Cardinal Health 107, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)55154-4321Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-4321Add 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
55154-4321-05515443210010 BLISTER PACK in 1 BAG (55154-4321-0) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 1, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 205231
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers
Product ID 55154-4321_33bc3e75-69e6-408b-ac57-6a0f8c39d9bcSPL ID 33bc3e75-69e6-408b-ac57-6a0f8c39d9bcSPL set ID bdb9e7cf-bfbb-48b4-a8be-9038820d8279RxCUI 830837, 830845, 830861UNII OLH94387TEUPC 0055154432108, 0055154262705, 0055154431705
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

N455154432100 followed by a unit qualifier and the quantity

Package 55154-4321-00. 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, USP (once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP (once-a-day dosage) 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 205231

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

FDA NDC Directory listings under ANDA 205231
ProductStrengthForm · routeLabelerProduct NDC
Diltiazem HydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralGolden State Medical Supply, Inc.51407-474
Diltiazem HydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralGolden State Medical Supply, Inc.51407-475
Diltiazem HydrochlorideDiltiazem hydrochloride 300 mg/1Capsule, Extended releaseOralGolden State Medical Supply, Inc.51407-476
Diltiazem HydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralCardinal Health 107, LLC55154-2627
Diltiazem HydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC24979-028
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC24979-026
Diltiazem HydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC24979-027
Diltiazem HydrochlorideDiltiazem hydrochloride 300 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC24979-029
Diltiazem HydrochlorideDiltiazem hydrochloride 360 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC24979-030
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-5416
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-2129
Diltiazem HydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-5452
Diltiazem HydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-5466
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-7217
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralCardinal Health 107, LLC55154-4317
Diltiazem HydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-7218
Diltiazem HydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-7219
Diltiazem HydrochlorideDiltiazem hydrochloride 300 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-7220
Diltiazem HydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-2739
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralGolden State Medical Supply, Inc.51407-473

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