Prescription drug · ANDA
Labetalol Hydrochloride NDC 70771-1163
Labetalol hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1163-1 | 70771116301 | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1163-1)Marketed from Dec 5, 2017 | |
| 70771-1163-3 | 70771116303 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1163-3)Marketed from Dec 5, 2017 | |
| 70771-1163-5 | 70771116305 | 500 TABLET, FILM COATED in 1 BOTTLE (70771-1163-5)Marketed from Dec 5, 2017 | |
| 70771-1163-9 | 70771116309 | 90 TABLET, FILM COATED in 1 BOTTLE (70771-1163-9)Marketed from Dec 5, 2017 |
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 — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207743
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 70771-1163_2be8d068-1830-4767-9e97-8d774d9a6001SPL ID 2be8d068-1830-4767-9e97-8d774d9a6001SPL set ID a3c0cc1e-1c01-4009-afdc-d35a66546aecRxCUI 896758, 896762, 896766UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470771116301followed by a unit qualifier and the quantityPackage 70771-1163-01. 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 .
Other NDCs under ANDA 207743
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 300 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-461 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-439 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-450 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-8192 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1164 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1165 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-799 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-798 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-800 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2143 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1242 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories Inc. | 68001-382 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories Inc. | 68001-381 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories Inc. | 68001-383 |