Prescription drug · NDA
Labetalol Hydrochloride NDC 0143-9183
Labetalol hydrochloride 5 mg/mL · Injection, Solution · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9183-10 | 00143918310 | 10 VIAL in 1 CARTON (0143-9183-10) / 4 mL in 1 VIAL (0143-9183-01)Marketed from Aug 28, 2025 |
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)
- Labetalol Hydrochloride
- Generic name (nonproprietary)
- labetalol hydrochloride
- Active ingredients
- Labetalol hydrochloride — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213330
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 0143-9183_d0e3d92d-d96e-4d5e-98ca-3d18a4bc82d8SPL ID d0e3d92d-d96e-4d5e-98ca-3d18a4bc82d8SPL set ID 99a715a0-4579-410c-b102-7ef6fab8db55RxCUI 2477889, 2479564, 2479566, 2479567UNII 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
N400143918310followed by a unit qualifier and the quantityPackage 00143-9183-10. 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)
Labetalol HCl Injection is indicated in severe hypertension, to lower blood pressure. Labetalol Hydrochloride (HCl) is a beta-adrenergic blocker. Labetalol HCl injection is indicated in severe hypertension, to lower blood pressure. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 213330
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 HCl in Sodium Chloridelabetalol hydrochloride | Labetalol hydrochloride 1 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9363 |
| Labetalol HCl in Sodium Chloridelabetalol hydrochloride | Labetalol hydrochloride 1 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9364 |
| Labetalol HCl in Sodium Chloridelabetalol hydrochloride | Labetalol hydrochloride 1 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9365 |
| Labetalol HCl in Dextroselabetalol hydrochloride | Labetalol hydrochloride 1 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9366 |