Prescription drug · ANDA
Labetalol HCL (Labetalol hydrochloride) NDC 50090-1290
Labetalol hydrochloride 200 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1290-0 | 5009012900050090129000 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1290-0)Marketed from Nov 28, 2014 | |
| 50090-1290-1 | 5009012900150090129001 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1290-1)Marketed from Aug 6, 2015 |
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 HCL
- Generic name (nonproprietary)
- labetalol hydrochloride
- Active ingredients
- Labetalol hydrochloride — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200908
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 50090-1290_0797ccb6-b00c-4ee4-91f3-a55705048b96SPL ID 0797ccb6-b00c-4ee4-91f3-a55705048b96SPL set ID 312dde0d-5147-483e-968f-4e0d46114176RxCUI 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
N450090129000followed by a unit qualifier and the quantityPackage 50090-1290-00. 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.
About NDC 50090-1290
- What is NDC 50090-1290?
- 50090-1290 is the product NDC for Labetalol HCL (labetalol hydrochloride), Labetalol hydrochloride 200 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Labetalol HCL (Labetalol Hydrochloride).
- What is the active ingredient?
- Labetalol hydrochloride.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. 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 HCL?
- 1 other product NDC are listed under this name. See all Labetalol HCL NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Labetalol HCL 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 HCl | Labetalol hydrochloride 5 mg/mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1602 | 51662-1602-0151662-1602-09 |