Prescription drug · ANDA
Labetalol Hydrochloride NDC 36000-324
Labetalol hydrochloride 5 mg/mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36000-324-02 | 36000032402 | 1 VIAL in 1 CARTON (36000-324-02) / 40 mL in 1 VIAL (36000-324-01)Marketed from Jan 26, 2021 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076051
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 36000-324_219d4dec-02d1-4d4b-88fd-01b1dbad3abcSPL ID 219d4dec-02d1-4d4b-88fd-01b1dbad3abcSPL set ID b17a7b3a-e7a5-4987-ae85-ad970e7540c7RxCUI 896771, 2477889UNII 1GEV3BAW9JUPC 0336000324014, 0336000320016, 0336000322010
- 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
N436000032402followed by a unit qualifier and the quantityPackage 36000-0324-02. 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.
Other NDCs under ANDA 076051
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 5 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 36000-320 |
| Labetalol Hydrochloride | Labetalol hydrochloride 5 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 36000-322 |