Prescription drug · ANDA

Labetalol Hydrochloride (Labetalol) NDC 10135-712

Labetalol 200 mg/1 · Tablet, Film coated · Oral · Marlex Pharmaceuticals Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)10135-712Labeler and product segments. Claims need a package NDC.
Product NDC at billing width10135-0712Add 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
10135-712-011013507120110135071201100 TABLET, FILM COATED in 1 BOTTLE (10135-712-01)Marketed from Oct 1, 2020
10135-712-051013507120510135071205500 TABLET, FILM COATED in 1 BOTTLE (10135-712-05)Marketed from Oct 1, 2020

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
Active ingredients
Labetalol — 200 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Marlex Pharmaceuticals IncNDC labeler code 10135
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075215
Marketing start
Listing expires
Other FDA classes
Adrenergic beta-Antagonists (Mechanism)
Identifiers
Product ID 10135-712_23e98950-6176-fa93-e063-6294a90a60a9SPL ID 23e98950-6176-fa93-e063-6294a90a60a9SPL set ID 28c91727-e5a8-48b3-a4df-d7bec8feda40RxCUI 896758, 896762, 896766UNII R5H8897N95
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

N410135071201 followed by a unit qualifier and the quantity

Package 10135-0712-01. 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 10135-712

What is NDC 10135-712?
10135-712 is the product NDC for Labetalol Hydrochloride (labetalol), Labetalol 200 mg/1 tablet, film coated, listed with the FDA by Marlex Pharmaceuticals Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Labetalol Hydrochloride (Labetalol).
What is the active ingredient?
Labetalol.
Who is the labeler?
Marlex Pharmaceuticals Inc, NDC labeler code 10135. 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 075215

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

FDA NDC Directory listings under ANDA 075215
ProductStrengthForm · routeLabelerProduct NDC
Labetalol HydrochlorideLabetalol 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4201
Labetalol HydrochlorideLabetalol 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9690
Labetalol HydrochloridelabetalolLabetalol 100 mg/1Tablet, Film coatedOralMarlex Pharmaceuticals Inc10135-711
Labetalol HydrochloridelabetalolLabetalol 300 mg/1Tablet, Film coatedOralMarlex Pharmaceuticals Inc10135-713
Labetalol HydrochlorideLabetalol 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1676
Labetalol HydrochlorideLabetalol 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1675
Labetalol HydrochlorideLabetalol 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1677
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6833
Labetalol HydrochlorideLabetalol 300 mg/1Tablet, Film coatedOralMethod Pharmaceuticals, LLC58657-604
Labetalol HydrochlorideLabetalol 100 mg/1Tablet, Film coatedOralMethod Pharmaceuticals, LLC58657-602
Labetalol HydrochlorideLabetalol 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3065
Labetalol HydrochlorideLabetalol 200 mg/1Tablet, Film coatedOralMethod Pharmaceuticals, LLC58657-603
Labetalol HydrochlorideLabetalol 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-1162
Labetalol HydrochlorideLabetalol 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-1161
Labetalol HydrochlorideLabetalol 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-1166
Labetalol HydrochlorideLabetalol 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-1163
Labetalol HydrochlorideLabetalol 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-1164
Labetalol HydrochlorideLabetalol 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-1165
Labetalol HydrochlorideLabetalol 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2057
Labetalol HydrochlorideLabetalol 300 mg/1Tablet, Film coatedOralMethod Pharmaceuticals, LLC58657-908

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