What is NDC 70518-3499?

70518-3499 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 3 package NDCs, shown above in 10- and 11-digit form.

REMEDYREPACK INC., NDC labeler code 70518. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Labetalol Hydrochloride NDC 70518-3499

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-3499Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-3499Add 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 NDC	11-digit (billing)	Package
70518-3499-0	7051834990070518349900	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3499-0)Marketed from Aug 25, 2022
70518-3499-1	7051834990170518349901	180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3499-1)Marketed from Sep 20, 2022
70518-3499-2	7051834990270518349902	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3499-2)Marketed from Sep 20, 2022

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 hydrochloride — 100 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: REMEDYREPACK INC.NDC labeler code 70518
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211953
Marketing start: Aug 25, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 70518-3499_4f1df0e1-e950-902d-e063-6394a90a6ff4SPL ID 4f1df0e1-e950-902d-e063-6394a90a6ff4SPL set ID ae5d7b3b-e444-48d3-9d85-9b07319f9374RxCUI 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

N470518349900 followed by a unit qualifier and the quantity

Package 70518-3499-00. 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 Apr 10, 2026.

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 70518-3499

What is NDC 70518-3499?: 70518-3499 is the product NDC for Labetalol Hydrochloride, Labetalol hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK 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?: REMEDYREPACK INC., NDC labeler code 70518. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	TabletOral	Coupler LLC	67046-1697	67046-1697-03
Labetalol Hydrochloride	Labetalol hydrochloride 100 mg/20mL	Injection, SolutionIntravenous	Armas Pharmaceuticals Inc.	72485-515	72485-0515-01
Labetalol Hydrochloride	Labetalol hydrochloride 100 mg/1	TabletOral	Coupler LLC	67046-1693	67046-1693-03
Labetalol Hydrochloride	Labetalol hydrochloride 300 mg/1	TabletOral	BluePoint Laboratories	68001-702	68001-0702-0068001-0702-03
Labetalol Hydrochloride	Labetalol hydrochloride 400 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-726	23155-0726-0123155-0726-05
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	TabletOral	NorthStar Rx LLC	72603-903	72603-0903-0172603-0903-02
Labetalol Hydrochloride	Labetalol hydrochloride 100 mg/1	TabletOral	NorthStar Rx LLC	72603-902	72603-0902-0172603-0902-02
Labetalol Hydrochloride	Labetalol hydrochloride 300 mg/1	TabletOral	NorthStar Rx LLC	72603-904	72603-0904-0172603-0904-02
Labetalol Hydrochloride	Labetalol hydrochloride 100 mg/1	TabletOral	BluePoint Laboratories	68001-700	68001-0700-0068001-0700-03
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	TabletOral	BluePoint Laboratories	68001-701	68001-0701-0068001-0701-03

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
Product	Strength	Form · route	Labeler	Product NDC
Labetalol Hydrochloride	Labetalol hydrochloride 100 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6741
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6774
Labetalol Hydrochloride	Labetalol hydrochloride 300 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7666
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7731
Labetalol Hydrochloride	Labetalol hydrochloride 100 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-784
Labetalol Hydrochloride	Labetalol hydrochloride 100 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-2156
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2169
Labetalol Hydrochloride	Labetalol hydrochloride 100 mg/1	Tablet, Film coatedOral	Advagen Pharma Ltd	72888-120
Labetalol Hydrochloride	Labetalol hydrochloride 200 mg/1	Tablet, Film coatedOral	Advagen Pharma Ltd	72888-121
Labetalol Hydrochloride	Labetalol hydrochloride 300 mg/1	Tablet, Film coatedOral	Advagen Pharma Ltd	72888-122
Labetalol Hydrochloride	Labetalol hydrochloride 300 mg/1	Tablet, Film coatedOral	Advagen Pharma Ltd	72888-468