Prescription drug · ANDA
Verapamil hydrochloride NDC 68083-447
Verapamil hydrochloride 2.5 mg/mL · Injection · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-447-25 | 68083044725 | 25 VIAL in 1 CARTON (68083-447-25) / 2 mL in 1 VIALMarketed from Oct 15, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Verapamil hydrochloride
- Generic name (nonproprietary)
- verapamil hydrochloride
- Active ingredients
- Verapamil hydrochloride — 2.5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Gland Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214361
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 68083-447_97d5fbfc-783f-4d2d-a178-1ac1ff0d6a55SPL ID 97d5fbfc-783f-4d2d-a178-1ac1ff0d6a55SPL set ID eb3c66f6-581f-422b-9ca2-9b877b323a33RxCUI 1665057, 1665061UNII V3888OEY5RUPC 0368083448059
- 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
N468083044725followed by a unit qualifier and the quantityPackage 68083-0447-25. 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 Verapamil Hydrochloride Injection, USP is indicated for the following: • Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong- Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration. • Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W- P-W) and Lown-Ganong-Levine (L…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214361
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 |
|---|---|---|---|---|
| Verapamil Hydrochloride | Verapamil hydrochloride 2.5 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-312 |
| Verapamil hydrochloride | Verapamil hydrochloride 2.5 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-448 |