Prescription drug · ANDA
Labetalol Hydrochloride NDC 68083-111
Labetalol hydrochloride 5 mg/mL · Injection, Solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-111-01 | 6808301110168083011101 | 10 VIAL, GLASS in 1 CARTON (68083-111-01) / 20 mL in 1 VIAL, GLASSMarketed from Apr 19, 2012 | |
| 68083-111-02 | 6808301110268083011102 | 10 VIAL, GLASS in 1 CARTON (68083-111-02) / 40 mL in 1 VIAL, GLASSMarketed from Apr 19, 2012 |
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, Solution
- Route
- Intravenous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090699
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 68083-111_f3cca933-34c3-4efd-81c6-02a4920dda16SPL ID f3cca933-34c3-4efd-81c6-02a4920dda16SPL set ID 48caf986-3126-48e1-afcd-16d65c9cfe00RxCUI 896771UNII 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 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
N468083011101followed by a unit qualifier and the quantityPackage 68083-0111-01. 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 & USAGE Labetalol hydrochloride injection is indicated for control of blood pressure in severe hypertension.
Excerpt only. Read the full label for complete information.
About NDC 68083-111
- What is NDC 68083-111?
- 68083-111 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 5 mg/mL injection, solution, listed with the FDA by Gland Pharma Limited. 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?
- Gland Pharma Limited, NDC labeler code 68083. 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 090699
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 | Fosun Pharma USA Inc. | 72266-102 |
| Labetalol Hydrochloride | Labetalol hydrochloride 5 mg/mL | InjectionIntravenous | Fosun Pharma USA Inc. | 72266-103 |
| Labetalol Hydrochloride | Labetalol hydrochloride 100 mg/20mL | InjectionIntravenous | Mullan Pharmaceutical Inc. | 83301-0058 |
| Labetalol Hydrochloride | Labetalol hydrochloride 200 mg/40mL | InjectionIntravenous | Mullan Pharmaceutical Inc. | 83301-0059 |