What is NDC 70771-1164?

70771-1164 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 200 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 70771. 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 70771-1164

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1164Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1164Add 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
70771-1164-1	7077111640170771116401	100 TABLET, FILM COATED in 1 BOTTLE (70771-1164-1)Marketed from Dec 5, 2017
70771-1164-3	7077111640370771116403	30 TABLET, FILM COATED in 1 BOTTLE (70771-1164-3)Marketed from Dec 5, 2017
70771-1164-5	7077111640570771116405	500 TABLET, FILM COATED in 1 BOTTLE (70771-1164-5)Marketed from Dec 5, 2017
70771-1164-9	7077111640970771116409	90 TABLET, FILM COATED in 1 BOTTLE (70771-1164-9)Marketed from Dec 5, 2017

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 200 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Zydus Lifesciences LimitedNDC labeler code 70771
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 70771-1164_2be8d068-1830-4767-9e97-8d774d9a6001SPL ID 2be8d068-1830-4767-9e97-8d774d9a6001SPL set ID a3c0cc1e-1c01-4009-afdc-d35a66546aecRxCUI 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

N470771116401 followed by a unit qualifier and the quantity

Package 70771-1164-01. 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 Nov 30, 2024.

Full label on DailyMed (opens in a new tab)

About NDC 70771-1164

What is NDC 70771-1164?: 70771-1164 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 200 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. 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 Lifesciences Limited, NDC labeler code 70771. 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 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
Labetalol Hydrochloride	Labetalol hydrochloride 5 mg/mL	InjectionIntravenous	Onesource Specialty Pharma Limited	83270-178	83270-0178-01

All 136 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 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 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