NDC codes

FDA NDC Directory
Product NDC (as listed)60760-784Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60760-0784Add 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
60760-784-90607600784906076007849090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-784-90)Marketed from Oct 5, 2022

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
Labeler
St. Mary's Medical Park PharmacyNDC labeler code 60760
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 60760-784_54d61630-01d9-0c4f-e063-6294a90a94e2SPL ID 54d61630-01d9-0c4f-e063-6294a90a94e2SPL set ID ed2293f8-2b82-c3db-e053-2995a90ad46cRxCUI 896758UNII 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

N460760078490 followed by a unit qualifier and the quantity

Package 60760-0784-90. 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 60760-784

What is NDC 60760-784?
60760-784 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by St. Mary's Medical Park Pharmacy. 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?
St. Mary's Medical Park Pharmacy, NDC labeler code 60760. 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 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
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1Tablet, Film coatedOralAdvagen Pharma Ltd72888-468

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