Prescription drug · ANDA
Labetalol Hydrochloride NDC 65145-124
Labetalol hydrochloride 5 mg/mL · Injection, Solution · Intravenous · Caplin Steriles Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65145-124-01 | 65145012401 | 1 VIAL, MULTI-DOSE in 1 CARTON (65145-124-01) / 20 mL in 1 VIAL, MULTI-DOSEMarketed from Feb 14, 2025 |
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)
- Labetalol Hydrochloride
- Generic name (nonproprietary)
- labetalol hydrochloride
- Active ingredients
- Labetalol hydrochloride — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Caplin Steriles Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214533
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 65145-124_24f8e54c-549c-41c6-aed6-f4036dd6f11fSPL ID 24f8e54c-549c-41c6-aed6-f4036dd6f11fSPL set ID 77152699-1ca8-442a-8cb4-80b0ffbec6f2RxCUI 896771UNII 1GEV3BAW9JUPC 0365145124012, 0365145125019
- Pharmacologic class
- beta-Adrenergic 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
N465145012401followed by a unit qualifier and the quantityPackage 65145-0124-01. 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 & USAGE Labetalol hydrochloride injection is indicated for control of blood pressure in severe hypertension.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214533
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 |
|---|---|---|---|---|
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/20mL | Injection, SolutionIntravenous | Armas Pharmaceuticals Inc. | 72485-515 |
| labetalol hydrochloride | Labetalol hydrochloride 5 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-317 |
| Labetalol Hydrochloride | Labetalol hydrochloride 5 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-125 |
| Labetalol Hydrochloride | Labetalol hydrochloride 5 mg/mL | Injection, SolutionIntravenous | NorthStar Rx LLC | 72603-146 |