Prescription drug · ANDA

Labetalol Hydrochloride NDC 72888-120

Labetalol hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Advagen Pharma Ltd

NDC codes

FDA NDC Directory
Product NDC (as listed)72888-120Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72888-0120Add 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
72888-120-0172888012001100 TABLET, FILM COATED in 1 BOTTLE (72888-120-01)Marketed from Aug 18, 2021
72888-120-0572888012005500 TABLET, FILM COATED in 1 BOTTLE (72888-120-05)Marketed from Aug 18, 2021

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 — 100 mg/1
Dosage form
Tablet, Film coated
Route
Oral
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 72888-120_4e76bf70-d160-7cdd-e063-6294a90a3b7fSPL ID 4e76bf70-d160-7cdd-e063-6294a90a3b7fSPL set ID 1c680447-b43a-4ff1-bc64-2c2174ca1c9aRxCUI 896758, 896762, 896766UNII 1GEV3BAW9JUPC 0372888120010, 0372888120058, 0372888121055, 0372888122014, 0372888122052, 0372888121017
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

N472888012001 followed by a unit qualifier and the quantity

Package 72888-0120-01. 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 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 300 mg/1Tablet, Film coatedOralAdvagen Pharma Ltd72888-468
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6741
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralRedpharm Drug67296-2156
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7666
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6774
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-784
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2169
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7731
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3499
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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Labetalol Hydrochloride NDC 72888-120 | Med-Code