Prescription drug · ANDA
Labetalol Hydrochloride NDC 71335-2434
Labetalol hydrochloride 300 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2434-1 | 71335243401 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2434-1)Marketed from Jul 15, 2024 | |
| 71335-2434-2 | 71335243402 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2434-2)Marketed from Jul 15, 2024 | |
| 71335-2434-3 | 71335243403 | 58 TABLET, FILM COATED in 1 BOTTLE (71335-2434-3)Marketed from Jul 15, 2024 | |
| 71335-2434-4 | 71335243404 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2434-4)Marketed from Jul 15, 2024 | |
| 71335-2434-5 | 71335243405 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2434-5)Marketed from Jul 15, 2024 |
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 — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209603
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 71335-2434_41d78266-20c3-e397-e063-6294a90a1c20SPL ID 41d78266-20c3-e397-e063-6294a90a1c20SPL set ID dafa7411-2857-4f5a-a587-4367cfbe2bfaRxCUI 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
N471335243401followed by a unit qualifier and the quantityPackage 71335-2434-01. 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 AND USAGE Labetalol HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209603
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 100 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-991 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7451 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7452 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-614 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | RedPharm Drug | 67296-2114 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-615 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-616 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7453 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals , Inc. | 68071-3878 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8512 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8513 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-061 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-060 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-062 |
| Labetalol Hydrochloride | Labetalol hydrochloride 400 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-063 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0181 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0182 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0184 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7457 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7458 |
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