Prescription drug · ANDA
Labetalol hydrochloride NDC 0591-0605
Labetalol hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-0605-01 | 00591060501 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0605-01)Marketed from Aug 3, 1998 | |
| 0591-0605-05 | 00591060505 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0605-05)Marketed from Aug 3, 1998 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075133
- Marketing start
- Marketing end
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 0591-0605_d5dfcb69-d2c4-49ca-a684-83c9e15b3b06SPL ID d5dfcb69-d2c4-49ca-a684-83c9e15b3b06SPL set ID a5b65a9b-6b8a-48a4-9c72-0e605bb309ebRxCUI 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
N400591060501followed by a unit qualifier and the quantityPackage 00591-0605-01. 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 075133
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 200 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6778 |
| Labetalol hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-095 |
| Labetalol hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7156 |