What is NDC 0409-0125?

0409-0125 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 5 mg/mL injection, solution, listed with the FDA by Hospira, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hospira, Inc., NDC labeler code 0409. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Labetalol Hydrochloride NDC 0409-0125

NDC codes

FDA NDC Directory

Product NDC (as listed)0409-0125Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00409-0125Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0409-0125-25	0040901252500409012525	25 VIAL, MULTI-DOSE in 1 TRAY (0409-0125-25) / 20 mL in 1 VIAL, MULTI-DOSE (0409-0125-01)Marketed from Aug 7, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Hospira, Inc.NDC labeler code 0409
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075240
Marketing start: Aug 7, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 0409-0125_6401712a-fe23-46ba-85b6-6265596cc778SPL ID 6401712a-fe23-46ba-85b6-6265596cc778
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.

How CPT relates to drug billing

NDC on a medical claim

N400409012525 followed by a unit qualifier and the quantity

Package 00409-0125-25. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0409-0125

What is NDC 0409-0125?: 0409-0125 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 5 mg/mL injection, solution, listed with the FDA by Hospira, Inc.. 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?: Hospira, Inc., NDC labeler code 0409. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Labetalol Hydrochloride NDCs
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 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

All 138 Labetalol Hydrochloride NDCs