Over-the-counter drug · ANDA

Leader All Day Pain Relief (Naproxen sodium) NDC 70000-0171

Naproxen sodium 220 mg/1 · Tablet, Film coated · Oral · Cardinal Health 110, LLC. dba Leader

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0171Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0171Add 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
70000-0171-370000017103700000171031 BOTTLE in 1 CARTON (70000-0171-3) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from Feb 16, 2017
70000-0171-570000017105700000171051 BOTTLE in 1 CARTON (70000-0171-5) / 24 TABLET, FILM COATED in 1 BOTTLEMarketed from Sep 23, 2021
70000-0171-670000017106700000171061 BOTTLE in 1 CARTON (70000-0171-6) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from May 24, 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)
Leader All Day Pain Relief
Generic name (nonproprietary)
naproxen sodium
Active ingredients
Naproxen sodium — 220 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Cardinal Health 110, LLC. dba LeaderNDC labeler code 70000
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074661
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 70000-0171_b063c471-3082-43b3-8fc5-ece0715c6df4SPL ID b063c471-3082-43b3-8fc5-ece0715c6df4SPL set ID dbf007f5-c792-43a7-8cc1-bfa617f3a7faRxCUI 849574UNII 9TN87S3A3C

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

N470000017103 followed by a unit qualifier and the quantity

Package 70000-0171-03. 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)

Uses • temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • menstrual cramps • headache • toothache • the common cold • temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70000-0171

What is NDC 70000-0171?
70000-0171 is the product NDC for Leader All Day Pain Relief (naproxen sodium), Naproxen sodium 220 mg/1 tablet, film coated, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Leader All Day Pain Relief (Naproxen Sodium).
What is the active ingredient?
Naproxen sodium.
Who is the labeler?
Cardinal Health 110, LLC. dba Leader, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Leader All Day Pain Relief?
1 other product NDC are listed under this name. See all Leader All Day Pain Relief 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 Leader All Day Pain Relief NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Leader All Day Pain Reliefnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralCardinal Health 110, LLC. dba Leader70000-020170000-0201-0270000-0201-0570000-0201-06

Other NDCs under ANDA 074661

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

FDA NDC Directory listings under ANDA 074661
ProductStrengthForm · routeLabelerProduct NDC
All Day Pain Reliefnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralWalgreen Company0363-0368
all day pain reliefnaproxen sodiumNaproxen sodium 200 mg/1Tablet, Film coatedOralWalgreen Company0363-0938
All Day Reliefnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralPublix Super Markets Inc56062-368
all day reliefnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralPublix Super Markets Inc56062-490
Basic Care Naproxen Sodiumnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-331
basic care naproxen sodiumnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-368
Basic Care Naproxen Sodiumnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-489
Berkley and Jensen Naproxen Sodiumnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralBJWC68391-368
betr headache pain reliefnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralLive Betr LLC80267-001
Care One Naproxen Sodiumnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralAmerican Sales Company41520-349
Care One Naproxen Sodiumnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralAmerican Sales Company41520-533
CareOne Naproxen Sodiumnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralAmerican Sales Company41520-507
DG Health Naproxen Sodiumnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralDolgencorp Inc55910-481
DG Health Naproxen Sodiumnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralDolgencorp Inc55910-490
dg health naproxen sodiumnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralDolgencorp Inc55910-500
dg health naproxen sodiumnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralDolgencorp Inc55910-729
equaline naproxen sodiumnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralUnited Natural Foods, Inc. dba UNFI41163-511
equaline naproxen sodiumnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralUnited Natural Foods, Inc. dba UNFI41163-707
exchange select naproxen sodiumnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralArmy & Air Force Exchange Service55301-368
foster and thrive all day pain reliefnaproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1137

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