Prescription drug · ANDA
Labetalol Hydrochloride NDC 23155-725
Labetalol hydrochloride 300 mg/1 · Tablet · Oral · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23155-725-01 | 2315507250123155072501 | 100 TABLET in 1 BOTTLE (23155-725-01)Marketed from Feb 22, 2020 | |
| 23155-725-05 | 2315507250523155072505 | 500 TABLET in 1 BOTTLE (23155-725-05)Marketed from Feb 22, 2020 |
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
- Route
- Oral
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.NDC labeler code 23155
- 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 23155-725_50a37968-605e-481b-af03-db963542a6c6SPL ID 50a37968-605e-481b-af03-db963542a6c6SPL set ID bf84ebae-3c91-4448-b1db-8e5ed3053866RxCUI 896758, 896762, 896766, 896983UNII 1GEV3BAW9JUPC 0323155726015, 0323155725018, 0323155724011, 0323155723014
- 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
N423155072501followed by a unit qualifier and the quantityPackage 23155-0725-01. 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.
About NDC 23155-725
- What is NDC 23155-725?
- 23155-725 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 300 mg/1 tablet, listed with the FDA by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Labetalol Hydrochloride.
- What is the active ingredient?
- Labetalol hydrochloride.
- Who is the labeler?
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., NDC labeler code 23155. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Labetalol Hydrochloride?
- 135 other product NDCs are listed under this name. See all Labetalol Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Labetalol Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/20mL | Injection, SolutionIntravenous | Armas Pharmaceuticals Inc. | 72485-515 | 72485-0515-01 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | TabletOral | Coupler LLC | 67046-1693 | 67046-1693-03 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | TabletOral | BluePoint Laboratories | 68001-702 | 68001-0702-0068001-0702-03 |
| Labetalol Hydrochloride | Labetalol hydrochloride 400 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-726 | 23155-0726-0123155-0726-05 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | TabletOral | NorthStar Rx LLC | 72603-902 | 72603-0902-0172603-0902-02 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | TabletOral | NorthStar Rx LLC | 72603-903 | 72603-0903-0172603-0903-02 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | TabletOral | NorthStar Rx LLC | 72603-904 | 72603-0904-0172603-0904-02 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | TabletOral | BluePoint Laboratories | 68001-700 | 68001-0700-0068001-0700-03 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | TabletOral | BluePoint Laboratories | 68001-701 | 68001-0701-0068001-0701-03 |
| Labetalol Hydrochloride | Labetalol hydrochloride 5 mg/mL | InjectionIntravenous | Onesource Specialty Pharma Limited | 83270-178 | 83270-0178-01 |
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 400 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-726 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-724 |
| 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 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | TabletOral | Coupler LLC | 67046-1697 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | TabletOral | Chartwell RX, LLC | 62135-791 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | TabletOral | Chartwell RX, LLC | 62135-792 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | TabletOral | Chartwell RX, LLC | 62135-800 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | TabletOral | NorthStar Rx LLC | 72603-902 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | TabletOral | NorthStar Rx LLC | 72603-903 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | TabletOral | NorthStar Rx LLC | 72603-904 |