Prescription drug · ANDA
Labetalol Hydrochloride NDC 55154-8192
Labetalol hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-8192-0 | 55154819200 | 10 BLISTER PACK in 1 BAG (55154-8192-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 16, 2019 |
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
- Cardinal Health 107, LLC
- 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 55154-8192_7062c435-020b-46e3-be45-2807abcbaeedSPL ID 7062c435-020b-46e3-be45-2807abcbaeedSPL set ID 63db5b00-e864-4b2d-84f2-00bf35211b9bRxCUI 896758, 896762UNII 1GEV3BAW9JUPC 0055154819206, 0055154214308
- 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
N455154819200followed by a unit qualifier and the quantityPackage 55154-8192-00. 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 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 200 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1164 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1163 |
| 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 |