What is NDC 68382-798?

68382-798 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 68382-798

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-798Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0798Add 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
68382-798-01	6838207980168382079801	100 TABLET, FILM COATED in 1 BOTTLE (68382-798-01)Marketed from Dec 5, 2017
68382-798-05	6838207980568382079805	500 TABLET, FILM COATED in 1 BOTTLE (68382-798-05)Marketed from Dec 5, 2017
68382-798-06	6838207980668382079806	30 TABLET, FILM COATED in 1 BOTTLE (68382-798-06)Marketed from Dec 5, 2017
68382-798-16	6838207981668382079816	90 TABLET, FILM COATED in 1 BOTTLE (68382-798-16)Marketed from Dec 5, 2017

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: Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207743
Marketing start: Dec 5, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 68382-798_49639538-dfdd-4312-9664-701e8bdbe191SPL ID 49639538-dfdd-4312-9664-701e8bdbe191SPL set ID 5942a5a8-c3c1-4ecb-921e-9bc92393bdf8RxCUI 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

N468382079801 followed by a unit qualifier and the quantity

Package 68382-0798-01. 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 Mar 2, 2026.

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.

Full label on DailyMed (opens in a new tab)

About NDC 68382-798

What is NDC 68382-798?: 68382-798 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 4 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?: Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 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

All 138 Labetalol Hydrochloride NDCs

Other NDCs under ANDA 207743

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 207743
Product	Strength	Form · route	Labeler	Product NDC
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-2143
Labetalol Hydrochloride	Labetalol hydrochloride 100 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-8192
Labetalol Hydrochloride	Labetalol hydrochloride 100 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-439
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-450
Labetalol Hydrochloride	Labetalol hydrochloride 300 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-461
Labetalol Hydrochloride	Labetalol hydrochloride 100 mg/1	Tablet, Film coatedOral	BluePoint Laboratories Inc.	68001-381
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	Tablet, Film coatedOral	BluePoint Laboratories Inc.	68001-382
Labetalol Hydrochloride	Labetalol hydrochloride 300 mg/1	Tablet, Film coatedOral	BluePoint Laboratories Inc.	68001-383
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-799
Labetalol Hydrochloride	Labetalol hydrochloride 300 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-800
Labetalol Hydrochloride	Labetalol hydrochloride 100 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1163
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1164
Labetalol Hydrochloride	Labetalol hydrochloride 300 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1165
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1242