What is NDC 68001-700?

68001-700 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 100 mg/1 tablet, listed with the FDA by BluePoint Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.

BluePoint Laboratories, 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?

135 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 68001-700

NDC codes

FDA NDC Directory

Product NDC (as listed)68001-700Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68001-0700Add 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
68001-700-00	6800107000068001070000	100 TABLET in 1 BOTTLE (68001-700-00)Marketed from Mar 15, 2026
68001-700-03	6800107000368001070003	500 TABLET in 1 BOTTLE (68001-700-03)Marketed from Jun 4, 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 — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: BluePoint LaboratoriesNDC labeler code 68001
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074787
Marketing start: Mar 15, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 68001-700_536f68cd-92b7-9015-e063-6394a90a9838SPL ID 536f68cd-92b7-9015-e063-6394a90a9838SPL set ID e4562c70-f245-4dbe-8fe1-0bb64a91a315RxCUI 896758, 896762, 896766UNII 1GEV3BAW9JUPC 0368001701006, 0368001702003, 0368001700009
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

N468001070000 followed by a unit qualifier and the quantity

Package 68001-0700-00. 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 4, 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 68001-700

What is NDC 68001-700?: 68001-700 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 100 mg/1 tablet, listed with the FDA by BluePoint Laboratories. 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, 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?: 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.

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 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 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
Labetalol Hydrochloride	Labetalol hydrochloride 5 mg/mL	InjectionIntravenous	Onesource Specialty Pharma Limited	83270-179	83270-0179-01

All 136 Labetalol Hydrochloride NDCs

Other NDCs under ANDA 074787

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

FDA NDC Directory listings under ANDA 074787
Product	Strength	Form · route	Labeler	Product NDC
Labetalol Hydrochloride	Labetalol hydrochloride 100 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-723
Labetalol Hydrochloride	Labetalol hydrochloride 400 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-726
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-724
Labetalol Hydrochloride	Labetalol hydrochloride 300 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-725
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	TabletOral	BluePoint Laboratories	68001-701
Labetalol Hydrochloride	Labetalol hydrochloride 300 mg/1	TabletOral	BluePoint Laboratories	68001-702
Labetalol Hydrochloride	Labetalol hydrochloride 100 mg/1	TabletOral	Coupler LLC	67046-1693
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	TabletOral	Coupler LLC	67046-1697
Labetalol Hydrochloride	Labetalol hydrochloride 100 mg/1	TabletOral	Chartwell RX, LLC	62135-791
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	TabletOral	Chartwell RX, LLC	62135-792
Labetalol Hydrochloride	Labetalol hydrochloride 300 mg/1	TabletOral	Chartwell RX, LLC	62135-800
Labetalol Hydrochloride	Labetalol hydrochloride 100 mg/1	TabletOral	NorthStar Rx LLC	72603-902
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	TabletOral	NorthStar Rx LLC	72603-903
Labetalol Hydrochloride	Labetalol hydrochloride 300 mg/1	TabletOral	NorthStar Rx LLC	72603-904