NDC codes

FDA NDC Directory
Product NDC (as listed)62135-792Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0792Add 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
62135-792-60621350792606213507926060 TABLET in 1 BOTTLE (62135-792-60)Marketed from Oct 24, 2023

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 — 200 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Chartwell RX, LLCNDC labeler code 62135
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074787
Marketing start
Listing expires
Other FDA classes
Adrenergic beta-Antagonists (Mechanism)
Identifiers
Product ID 62135-792_44fde4f9-0088-6476-e063-6394a90a6a92SPL ID 44fde4f9-0088-6476-e063-6394a90a6a92SPL set ID ac439c08-1e47-4306-8308-b31d7a1a443cRxCUI 896758, 896762, 896766UNII 1GEV3BAW9JUPC 0362135791605, 0362135800604, 0362135792602
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

N462135079260 followed by a unit qualifier and the quantity

Package 62135-0792-60. 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 HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets 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 62135-792

What is NDC 62135-792?
62135-792 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 200 mg/1 tablet, listed with the FDA by Chartwell RX, 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?
Chartwell RX, LLC, NDC labeler code 62135. 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?
135 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 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 100 mg/1TabletOralNorthStar Rx LLC72603-90272603-0902-0172603-0902-02
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1TabletOralNorthStar Rx LLC72603-90372603-0903-0172603-0903-02
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
Labetalol HydrochlorideLabetalol hydrochloride 5 mg/mLInjectionIntravenousOnesource Specialty Pharma Limited83270-17883270-0178-01

All 136 Labetalol Hydrochloride NDCs

Other NDCs under ANDA 074787

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

FDA NDC Directory listings under ANDA 074787
ProductStrengthForm · routeLabelerProduct NDC
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-723
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-724
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-725
Labetalol HydrochlorideLabetalol hydrochloride 400 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-726
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1TabletOralChartwell RX, LLC62135-791
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1TabletOralChartwell RX, LLC62135-800
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1TabletOralCoupler LLC67046-1693
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1TabletOralBluePoint Laboratories68001-700
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1TabletOralBluePoint Laboratories68001-701
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1TabletOralBluePoint Laboratories68001-702
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1TabletOralNorthStar Rx LLC72603-902
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1TabletOralNorthStar Rx LLC72603-903
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1TabletOralNorthStar Rx LLC72603-904

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