Prescription drug · ANDA
LABETALOL HCl NDC 51662-1602
Labetalol hydrochloride 5 mg/mL · Injection · Intravenous · HF Acquisition Co LLC, DBA HealthFirst
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51662-1602-1 | 51662160201 | 1 VIAL in 1 BOX, UNIT-DOSE (51662-1602-1) / 20 mL in 1 VIALMarketed from Aug 29, 2022 | |
| 51662-1602-9 | 51662160209 | 20 mL in 1 VIAL (51662-1602-9)Marketed from Oct 1, 2022 |
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 HCl
- Generic name (nonproprietary)
- labetalol hcl
- Active ingredients
- Labetalol hydrochloride — 5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075303
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 51662-1602_ea035948-1a97-5d6e-e053-2995a90a3e7bSPL ID ea035948-1a97-5d6e-e053-2995a90a3e7bSPL set ID e76c4b37-4a34-249d-e053-2995a90aa9beRxCUI 896771UNII 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
N451662160201followed by a unit qualifier and the quantityPackage 51662-1602-01. 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 HCl Injection, USP is indicated for control of blood pressure in severe hypertension.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075303
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 | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9320 |
| Labetalol Hydrochloride | Labetalol hydrochloride 5 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9622 |
| Labetalol Hydrochloride | Labetalol hydrochloride 5 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9623 |
| Labetalol Hydrochloride | Labetalol hydrochloride 5 mg/mL | InjectionIntravenous | Civica, Inc. | 72572-350 |