Prescription drug · ANDA
Labetalol Hydrochloride NDC 72603-902
Labetalol hydrochloride 100 mg/1 · Tablet · Oral · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-902-01 | 72603090201 | 100 TABLET in 1 BOTTLE (72603-902-01)Marketed from Mar 19, 2026 | |
| 72603-902-02 | 72603090202 | 500 TABLET in 1 BOTTLE (72603-902-02)Marketed from Mar 19, 2026 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NorthStar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074787
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 72603-902_2a23ecd8-4a58-4f02-8bcd-e112364b12e9SPL ID 2a23ecd8-4a58-4f02-8bcd-e112364b12e9SPL set ID 5bd81a8a-a480-4c8d-bd4f-3158412e6a73RxCUI 896758, 896762, 896766UNII 1GEV3BAW9JUPC 0372603902013, 0372603904017, 0372603903027, 0372603904024, 0372603903010, 0372603902020
- 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
N472603090201followed by a unit qualifier and the quantityPackage 72603-0902-01. 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 074787
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 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-723 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | TabletOral | NorthStar Rx LLC | 72603-904 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | TabletOral | NorthStar Rx LLC | 72603-903 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | TabletOral | Chartwell RX, LLC | 62135-792 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | TabletOral | Chartwell RX, LLC | 62135-791 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | TabletOral | Chartwell RX, LLC | 62135-800 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-724 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-725 |
| Labetalol Hydrochloride | Labetalol hydrochloride 400 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-726 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | TabletOral | BluePoint Laboratories | 68001-700 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | TabletOral | BluePoint Laboratories | 68001-701 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | TabletOral | BluePoint Laboratories | 68001-702 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | TabletOral | Coupler LLC | 67046-1693 |