Prescription drug · ANDA
Labetalol hydrochloride NDC 71205-095
Labetalol hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-095-30 | 7120500953071205009530 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-30)Marketed from Aug 1, 2018 | |
| 71205-095-60 | 7120500956071205009560 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-60)Marketed from Aug 1, 2018 | |
| 71205-095-90 | 7120500959071205009590 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-095-90)Marketed from Aug 1, 2018 |
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, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075133
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 71205-095_5179866d-f336-4e03-85b0-972fbedb6b9eSPL ID 5179866d-f336-4e03-85b0-972fbedb6b9eSPL set ID c0301841-e209-4242-bace-58a20e6dd01bRxCUI 896758UNII 1GEV3BAW9JUPC 0371205095901
- 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
N471205009530followed by a unit qualifier and the quantityPackage 71205-0095-30. 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 71205-095
- What is NDC 71205-095?
- 71205-095 is the product NDC for Labetalol hydrochloride, Labetalol hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 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?
- Proficient Rx LP, NDC labeler code 71205. 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 075133
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 200 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6778 |
| Labetalol hydrochloride | Labetalol hydrochloride 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7156 |