NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1242Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1242Add 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
71335-1242-17133512420130 TABLET, FILM COATED in 1 BOTTLE (71335-1242-1)Marketed from Nov 27, 2019
71335-1242-27133512420290 TABLET, FILM COATED in 1 BOTTLE (71335-1242-2)Marketed from Jul 23, 2021
71335-1242-37133512420360 TABLET, FILM COATED in 1 BOTTLE (71335-1242-3)Marketed from Jun 6, 2019

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
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 71335-1242_8d4c15db-5ffc-40eb-b025-9f501352c455SPL ID 8d4c15db-5ffc-40eb-b025-9f501352c455SPL set ID 9c3bb751-c425-43ff-b530-2460b568b689RxCUI 896762UNII 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

N471335124201 followed by a unit qualifier and the quantity

Package 71335-1242-01. 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 .

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)

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 100 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1163
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 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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in