NDC codes

FDA NDC Directory
Product NDC (as listed)55154-8192Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-8192Add 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
55154-8192-0551548192005515481920010 BLISTER PACK in 1 BAG (55154-8192-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 16, 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 — 100 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Cardinal Health 107, LLCNDC labeler code 55154
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 55154-8192_7062c435-020b-46e3-be45-2807abcbaeedSPL ID 7062c435-020b-46e3-be45-2807abcbaeedSPL set ID 63db5b00-e864-4b2d-84f2-00bf35211b9bRxCUI 896758, 896762UNII 1GEV3BAW9JUPC 0055154819206, 0055154214308
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

N455154819200 followed by a unit qualifier and the quantity

Package 55154-8192-00. 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 .

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 55154-8192

What is NDC 55154-8192?
55154-8192 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Cardinal Health 107, LLC. It has 1 package NDC, 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?
Cardinal Health 107, LLC, NDC labeler code 55154. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1TabletOralCoupler LLC67046-169767046-1697-03
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/20mLInjection, SolutionIntravenousArmas Pharmaceuticals Inc.72485-51572485-0515-01
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1TabletOralCoupler LLC67046-169367046-1693-03
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1TabletOralBluePoint Laboratories68001-70268001-0702-0068001-0702-03
Labetalol HydrochlorideLabetalol hydrochloride 400 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-72623155-0726-0123155-0726-05
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1TabletOralNorthStar Rx LLC72603-90372603-0903-0172603-0903-02
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1TabletOralNorthStar Rx LLC72603-90272603-0902-0172603-0902-02
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1TabletOralNorthStar Rx LLC72603-90472603-0904-0172603-0904-02
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1TabletOralBluePoint Laboratories68001-70068001-0700-0068001-0700-03
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1TabletOralBluePoint Laboratories68001-70168001-0701-0068001-0701-03

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
ProductStrengthForm · routeLabelerProduct NDC
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-2143
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 300 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-461
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralBluePoint Laboratories Inc.68001-381
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralBluePoint Laboratories Inc.68001-382
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1Tablet, Film coatedOralBluePoint Laboratories Inc.68001-383
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-798
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-799
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1Tablet, Film coatedOralZydus Pharmaceuticals USA Inc.68382-800
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1163
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 coatedOralBryant Ranch Prepack71335-1242

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