Prescription drug · ANDA
Labetalol Hydrochloride NDC 83270-179
Labetalol hydrochloride 5 mg/mL · Injection · Intravenous · Onesource Specialty Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83270-179-01 | 8327001790183270017901 | 1 VIAL, MULTI-DOSE in 1 CARTON (83270-179-01) / 40 mL in 1 VIAL, MULTI-DOSEMarketed from Feb 27, 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 — 5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Onesource Specialty Pharma LimitedNDC labeler code 83270
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079134
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 83270-179_556364b1-527d-bd9c-e063-6394a90aee8cSPL ID 556364b1-527d-bd9c-e063-6394a90aee8cSPL set ID 6cb2c117-584c-4440-acfb-e4b1af4dc509RxCUI 896771UNII 1GEV3BAW9JUPC 0383270178014
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N483270017901followed by a unit qualifier and the quantityPackage 83270-0179-01. 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 Injection, USP is indicated for control of blood pressure in severe hypertension
Excerpt only. Read the full label for complete information.
About NDC 83270-179
- What is NDC 83270-179?
- 83270-179 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 5 mg/mL injection, listed with the FDA by Onesource Specialty Pharma Limited. It has 1 package NDC, 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?
- Onesource Specialty Pharma Limited, NDC labeler code 83270. 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 079134
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 5 mg/mL | InjectionIntravenous | Onesource Specialty Pharma Limited | 83270-178 |