Prescription drug · ANDA

Labetalol Hydrochloride NDC 63629-1166

Labetalol 300 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)63629-1166Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-1166Add 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
63629-1166-163629116601500 TABLET, FILM COATED in 1 BOTTLE (63629-1166-1)Marketed from Nov 22, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 300 mg/1
Dosage form
Tablet, Film coated
Route
Oral
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 63629-1166_bd6d03a3-c34b-4817-a263-0bc27dd645faSPL ID bd6d03a3-c34b-4817-a263-0bc27dd645faSPL set ID 5a39bb96-4a60-49e8-859c-16bda0fe18e4RxCUI 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

N463629116601 followed by a unit qualifier and the quantity

Package 63629-1166-01. 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 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 coatedOralBryant Ranch Prepack72162-1675
Labetalol HydrochlorideLabetalol 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1676
Labetalol HydrochlorideLabetalol 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1677
Labetalol HydrochlorideLabetalol 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3065
Labetalol HydrochlorideLabetalol 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2057
Labetalol HydrochloridelabetalolLabetalol 100 mg/1Tablet, Film coatedOralMarlex Pharmaceuticals Inc10135-711
Labetalol HydrochloridelabetalolLabetalol 200 mg/1Tablet, Film coatedOralMarlex Pharmaceuticals Inc10135-712
Labetalol HydrochloridelabetalolLabetalol 300 mg/1Tablet, Film coatedOralMarlex Pharmaceuticals Inc10135-713
Labetalol HydrochlorideLabetalol 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2876
Labetalol HydrochlorideLabetalol hydrochloride 100 mg/1Tablet, Film coatedOralInnogenix, Inc.71247-126
Labetalol HydrochlorideLabetalol hydrochloride 200 mg/1Tablet, Film coatedOralInnogenix, Inc.71247-127
Labetalol HydrochlorideLabetalol hydrochloride 300 mg/1Tablet, Film coatedOralInnogenix, Inc.71247-130
Labetalol HydrochlorideLabetalol 300 mg/1Tablet, Film coatedOralMethod Pharmaceuticals, LLC58657-604
Labetalol HydrochlorideLabetalol 100 mg/1Tablet, Film coatedOralMethod Pharmaceuticals, LLC58657-602
Labetalol HydrochlorideLabetalol 200 mg/1Tablet, Film coatedOralMethod Pharmaceuticals, LLC58657-603
Labetalol HydrochlorideLabetalol 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-1163
Labetalol HydrochlorideLabetalol 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-1161
Labetalol HydrochlorideLabetalol 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-1162
Labetalol HydrochlorideLabetalol 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-1164
Labetalol HydrochlorideLabetalol 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-1165

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