Diltiazem Hydrochloride NDC 0641-9218

NDC codes

FDA NDC Directory

Product NDC (as listed)0641-9218Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00641-9218Add 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 NDC	11-digit (billing)	Package	Copy
0641-9218-10	00641921810	10 VIAL in 1 CARTON (0641-9218-10) / 10 mL in 1 VIAL (0641-9218-01)Marketed from Dec 17, 2008

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 — 5 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078538
Marketing start: Dec 17, 2008
Listing expires: Dec 31, 2027
Other FDA classes: Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers: Product ID 0641-9218_82ec8594-72c0-4636-9b36-74fe724f750eSPL ID 82ec8594-72c0-4636-9b36-74fe724f750eSPL set ID 734beeef-3968-4137-af2c-276e8a9317dfRxCUI 1791229, 1791232, 1791233UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N400641921810 followed by a unit qualifier and the quantity

Package 00641-9218-10. 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 Feb 9, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Diltiazem Hydrochloride Injection is indicated for the following: Atrial Fibrillation or Atrial Flutter Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome. Paroxysmal Supraventricular Tachycardia Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Un…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078538

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

FDA NDC Directory listings under ANDA 078538
Product	Strength	Form · route	Labeler	Product NDC
Diltiazem Hydrochloride	Diltiazem hydrochloride 5 mg/mL	InjectionIntravenous	Medical Purchasing Solutions, LLC	71872-7063
Diltiazem Hydrochloride	Diltiazem hydrochloride 5 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0641-9217
Diltiazem Hydrochloride	Diltiazem hydrochloride 5 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0641-9219
Diltiazem Hydrochloride	Diltiazem hydrochloride 5 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0641-6013
Diltiazem Hydrochloride	Diltiazem hydrochloride 5 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0641-6014
Diltiazem Hci	Diltiazem hydrochloride 5 mg/mL	InjectionIntravenous	HF Acquisition Co LLC, DBA HealthFirst	51662-1335
Diltiazem Hydrochloride	Diltiazem hydrochloride 5 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0641-6015