NDC codes

FDA NDC Directory
Product NDC (as listed)72888-468Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72888-0468Add 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
72888-468-017288804680172888046801500 TABLET, FILM COATED in 1 BOTTLE (72888-468-01)Marketed from May 20, 2025
72888-468-027288804680272888046802100 TABLET, FILM COATED in 1 BOTTLE (72888-468-02)Marketed from May 20, 2025

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 — 300 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Advagen Pharma LtdNDC labeler code 72888
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211953
Marketing start
Listing expires
Other FDA classes
Adrenergic beta-Antagonists (Mechanism)
Identifiers
Product ID 72888-468_4e7597b8-afba-8b90-e063-6394a90a85e4SPL ID 4e7597b8-afba-8b90-e063-6394a90a85e4SPL set ID 106a0959-5830-489f-ba60-afd4eb0fac36RxCUI 896766UNII 1GEV3BAW9JUPC 0372888468020, 0372888468013
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

N472888046801 followed by a unit qualifier and the quantity

Package 72888-0468-01. 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)

About NDC 72888-468

What is NDC 72888-468?
72888-468 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 300 mg/1 tablet, film coated, listed with the FDA by Advagen Pharma Ltd. 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?
Advagen Pharma Ltd, NDC labeler code 72888. 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 211953

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

FDA NDC Directory listings under ANDA 211953
ProductStrengthForm · routeLabelerProduct NDC
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6741
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6774
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7666
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7731
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-784
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralRedpharm Drug67296-2156
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3499
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2169
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralAdvagen Pharma Ltd72888-120
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralAdvagen Pharma Ltd72888-121
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1Tablet, Film coatedOralAdvagen Pharma Ltd72888-122

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