NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1163Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1163Add 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 NDC11-digit (billing)PackageCopy
70771-1163-170771116301100 TABLET, FILM COATED in 1 BOTTLE (70771-1163-1)Marketed from Dec 5, 2017
70771-1163-37077111630330 TABLET, FILM COATED in 1 BOTTLE (70771-1163-3)Marketed from Dec 5, 2017
70771-1163-570771116305500 TABLET, FILM COATED in 1 BOTTLE (70771-1163-5)Marketed from Dec 5, 2017
70771-1163-97077111630990 TABLET, FILM COATED in 1 BOTTLE (70771-1163-9)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 — 100 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207743
Marketing start
Listing expires
Other FDA classes
Adrenergic beta-Antagonists (Mechanism)
Identifiers
Product ID 70771-1163_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

N470771116301 followed by a unit qualifier and the quantity

Package 70771-1163-01. 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 .

Full label on DailyMed (opens in a new tab)

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
ProductStrengthForm · routeLabelerProduct NDC
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-461
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-439
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-450
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-8192
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1164
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1165
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-799
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-798
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-800
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-2143
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1242
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralBluePoint Laboratories Inc.68001-382
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralBluePoint Laboratories Inc.68001-381
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1Tablet, Film coatedOralBluePoint Laboratories Inc.68001-383

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