Prescription drug · ANDA
Diltiazem Hydrochloride NDC 0641-6013
Diltiazem hydrochloride 5 mg/mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6013-10 | 00641601310 | 10 VIAL in 1 CARTON (0641-6013-10) / 5 mL in 1 VIAL (0641-6013-01)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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078538
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 0641-6013_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.
- NDC on a medical claim
N400641601310followed by a unit qualifier and the quantityPackage 00641-6013-10. 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 .
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.
Other NDCs under ANDA 078538
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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. | 0641-9218 |
| 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. | 0641-6014 |
| 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 |