Prescription drug · ANDA
Labetalol Hydrochloride NDC 70121-2428
Labetalol hydrochloride 5 mg/mL · Injection, Solution · Intravenous · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70121-2428-3 | 70121242803 | 24 CARTON in 1 CARTON (70121-2428-3) / 1 SYRINGE, GLASS in 1 CARTON (70121-2428-1) / 4 mL in 1 SYRINGE, GLASSMarketed from Oct 2, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218870
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 70121-2428_1878c304-0b8f-402d-8dd1-7d6be6108d07SPL ID 1878c304-0b8f-402d-8dd1-7d6be6108d07SPL set ID dbf1e4c7-7c0c-4f2f-8cad-96bc6b800cfcRxCUI 2727439UNII 1GEV3BAW9J
- 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
N470121242803followed by a unit qualifier and the quantityPackage 70121-2428-03. 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 Labetalol hydrochloride injection is indicated for control of blood pressure in severe hypertension.
Excerpt only. Read the full label for complete information.