Prescription drug · ANDA

Labetalol Hydrochloride NDC 70377-062

Labetalol hydrochloride 300 mg/1 · Tablet, Film coated · Oral · Biocon Pharma Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)70377-062Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70377-0062Add 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
70377-062-11703770062117037700621130 TABLET, FILM COATED in 1 BOTTLE (70377-062-11)Marketed from May 27, 2021
70377-062-127037700621270377006212100 TABLET, FILM COATED in 1 BOTTLE (70377-062-12)Marketed from May 27, 2021
70377-062-137037700621370377006213500 TABLET, FILM COATED in 1 BOTTLE (70377-062-13)Marketed from May 27, 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 — 300 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Biocon Pharma Inc.NDC labeler code 70377
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209603
Marketing start
Listing expires
Other FDA classes
Adrenergic beta-Antagonists (Mechanism)
Identifiers
Product ID 70377-062_f285cda1-e518-405e-9362-292ae2e14954SPL ID f285cda1-e518-405e-9362-292ae2e14954SPL set ID 27e4ab03-c17b-4268-912c-e45a5e8f8dd8RxCUI 896758, 896762, 896766, 896983UNII 1GEV3BAW9JUPC 0370377061134, 0370377060120, 0370377063121, 0370377063114
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

N470377006211 followed by a unit qualifier and the quantity

Package 70377-0062-11. 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 70377-062

What is NDC 70377-062?
70377-062 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 300 mg/1 tablet, film coated, listed with the FDA by Biocon Pharma Inc.. It has 3 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?
Biocon Pharma Inc., NDC labeler code 70377. 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 209603

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

FDA NDC Directory listings under ANDA 209603
ProductStrengthForm · routeLabelerProduct NDC
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1Tablet, Film coatedOralRedPharm Drug67296-2114
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralProficient Rx LP82804-289
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7451
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7452
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7453
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-615
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-614
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals , Inc.68071-3878
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-616
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7458
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7457
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralBiocon Pharma Inc.70377-060
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralBiocon Pharma Inc.70377-061
Labetalol HydrochlorideLabetalol hydrochloride 400 mg/1Tablet, Film coatedOralBiocon Pharma Inc.70377-063
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8512
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7743
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8513
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7524
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7523
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-0181

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