Prescription drug · ANDA
Labetalol Hydrochloride NDC 72888-122
Labetalol hydrochloride 300 mg/1 · Tablet, Film coated · Oral · Advagen Pharma Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72888-122-01 | 72888012201 | 100 TABLET, FILM COATED in 1 BOTTLE (72888-122-01)Marketed from Aug 18, 2021 | |
| 72888-122-05 | 72888012205 | 500 TABLET, FILM COATED in 1 BOTTLE (72888-122-05)Marketed from Aug 18, 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 — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Advagen Pharma Ltd
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211953
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 72888-122_4e76bf70-d160-7cdd-e063-6294a90a3b7fSPL ID 4e76bf70-d160-7cdd-e063-6294a90a3b7fSPL set ID 1c680447-b43a-4ff1-bc64-2c2174ca1c9aRxCUI 896758, 896762, 896766UNII 1GEV3BAW9JUPC 0372888120010, 0372888120058, 0372888121055, 0372888122014, 0372888122052, 0372888121017
- 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
N472888012201followed by a unit qualifier and the quantityPackage 72888-0122-01. 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 hydrochloride tablets USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP 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 211953
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 | Advagen Pharma Ltd | 72888-468 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6741 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2156 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7666 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6774 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-784 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2169 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7731 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3499 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Advagen Pharma Ltd | 72888-120 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | Advagen Pharma Ltd | 72888-121 |