What is NDC 68001-383?

68001-383 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 300 mg/1 tablet, film coated, listed with the FDA by BluePoint Laboratories Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

BluePoint Laboratories Inc., NDC labeler code 68001. 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 68001-383

NDC codes

FDA NDC Directory

Product NDC (as listed)68001-383Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68001-0383Add 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
68001-383-00	6800103830068001038300	100 TABLET, FILM COATED in 1 BOTTLE (68001-383-00)Marketed from Feb 18, 2019
68001-383-03	6800103830368001038303	500 TABLET, FILM COATED in 1 BOTTLE (68001-383-03)Marketed from Feb 18, 2019

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 — 300 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: BluePoint Laboratories Inc.NDC labeler code 68001
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207743
Marketing start: Feb 18, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 68001-383_53bd2b04-9eae-6b4f-e063-6394a90a0751SPL ID 53bd2b04-9eae-6b4f-e063-6394a90a0751SPL set ID 63ede355-42ec-4c52-a941-51e5f6b35ed6RxCUI 896758, 896762, 896766UNII 1GEV3BAW9JUPC 0368001381000, 0368001382007, 0368001383004
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

N468001038300 followed by a unit qualifier and the quantity

Package 68001-0383-00. 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 Jun 8, 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 68001-383

What is NDC 68001-383?: 68001-383 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 300 mg/1 tablet, film coated, listed with the FDA by BluePoint Laboratories Inc.. 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?: BluePoint Laboratories Inc., NDC labeler code 68001. 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 100 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-798
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