Prescription drug · ANDA
Labetalol Hydrochloride NDC 51407-615
Labetalol hydrochloride 200 mg/1 · Tablet, Film coated · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)51407-615Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51407-0615Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-615-01 | 5140706150151407061501 | 100 TABLET, FILM COATED in 1 BOTTLE (51407-615-01)Marketed from Dec 3, 2021 | |
| 51407-615-05 | 5140706150551407061505 | 500 TABLET, FILM COATED in 1 BOTTLE (51407-615-05)Marketed from Dec 3, 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 — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Golden State Medical Supply, Inc.NDC labeler code 51407
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209603
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 51407-615_4f9b6911-a34d-5d03-e063-6294a90a7b82SPL ID 4f9b6911-a34d-5d03-e063-6294a90a7b82SPL set ID d5ce687f-4a37-d3e6-e053-2995a90aa974RxCUI 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
N451407061501followed by a unit qualifier and the quantityPackage 51407-0615-01. 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 HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets 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 51407-615
- What is NDC 51407-615?
- 51407-615 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 200 mg/1 tablet, film coated, listed with the FDA by Golden State Medical Supply, 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?
- Golden State Medical Supply, Inc., NDC labeler code 51407. 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?
- 137 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 200 mg/1 | TabletOral | Coupler LLC | 67046-1697 | 67046-1697-03 |
| 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 200 mg/1 | TabletOral | NorthStar Rx LLC | 72603-903 | 72603-0903-0172603-0903-02 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | TabletOral | NorthStar Rx LLC | 72603-902 | 72603-0902-0172603-0902-02 |
| 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 |
Other NDCs under ANDA 209603
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 | RedPharm Drug | 67296-2114 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-289 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7451 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7452 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7453 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-614 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals , Inc. | 68071-3878 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-616 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7458 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7457 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-060 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-061 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-062 |
| Labetalol Hydrochloride | Labetalol hydrochloride 400 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-063 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8512 |
| Labetalol Hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7743 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8513 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7524 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7523 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0181 |
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