What is NDC 0641-6015?

0641-6015 is the product NDC for Diltiazem Hydrochloride, Diltiazem hydrochloride 5 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0641. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Diltiazem Hydrochloride?

223 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Diltiazem Hydrochloride NDC 0641-6015

NDC codes

FDA NDC Directory

Product NDC (as listed)0641-6015Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00641-6015Add 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
0641-6015-10	0064160151000641601510	10 VIAL in 1 CARTON (0641-6015-10) / 25 mL in 1 VIAL (0641-6015-01)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.NDC labeler code 0641
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078538
Marketing start: Dec 17, 2008
Listing expires: Dec 31, 2026
Other FDA classes: Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers: Product ID 0641-6015_fb823cdb-b2d1-4821-ba0e-d1af2cee72c0SPL ID fb823cdb-b2d1-4821-ba0e-d1af2cee72c0SPL set ID 453b73bd-c52d-4d72-a0b3-47588e723e0bRxCUI 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

N400641601510 followed by a unit qualifier and the quantity

Package 00641-6015-10. 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 Apr 9, 2024.

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)

About NDC 0641-6015

What is NDC 0641-6015?: 0641-6015 is the product NDC for Diltiazem Hydrochloride, Diltiazem hydrochloride 5 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diltiazem Hydrochloride.
What is the active ingredient?: Diltiazem hydrochloride.
Who is the labeler?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0641. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Diltiazem Hydrochloride?: 223 other product NDCs are listed under this name. See all Diltiazem Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Diltiazem Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Diltiazem Hydrochloride	Diltiazem hydrochloride 60 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-322	27808-0322-01
Diltiazem Hydrochloride	Diltiazem hydrochloride 90 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-323	27808-0323-01
Diltiazem Hydrochloride	Diltiazem hydrochloride 120 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-324	27808-0324-01
Diltiazem hydrochloride	Diltiazem hydrochloride 30 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1929	70771-1929-0170771-1929-05
Diltiazem hydrochloride	Diltiazem hydrochloride 60 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1930	70771-1930-0170771-1930-05
Diltiazem hydrochloride	Diltiazem hydrochloride 90 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1931	70771-1931-0170771-1931-05
Diltiazem hydrochloride	Diltiazem hydrochloride 120 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1932	70771-1932-0170771-1932-05
Diltiazem hydrochloride	Diltiazem hydrochloride 30 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-199	72578-0199-0172578-0199-05
Diltiazem hydrochloride	Diltiazem hydrochloride 60 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-200	72578-0200-0172578-0200-05
Diltiazem hydrochloride	Diltiazem hydrochloride 90 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-201	72578-0201-0172578-0201-05

All 224 Diltiazem Hydrochloride NDCs

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 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.	0641-6013
Diltiazem Hydrochloride	Diltiazem hydrochloride 5 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0641-6014
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.	0641-9218
Diltiazem Hydrochloride	Diltiazem hydrochloride 5 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0641-9219
Diltiazem Hydrochloride	Diltiazem hydrochloride 5 mg/mL	InjectionIntravenous	Medical Purchasing Solutions, LLC	71872-7063