Over-the-counter drug · ANDA

Leader Ibuprofen (Ibuprofen) NDC 70000-0176

Ibuprofen 200 mg/1 · Tablet, Film coated · Oral · Cardinal Health 110, LLC. dba Leader

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0176Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0176Add 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
70000-0176-170000017601700000176011 BOTTLE in 1 CARTON (70000-0176-1) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Nov 30, 2016
70000-0176-470000017604700000176041 BOTTLE in 1 CARTON (70000-0176-4) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from May 4, 2017
70000-0176-570000017605700000176051 BOTTLE in 1 CARTON (70000-0176-5) / 500 TABLET, FILM COATED in 1 BOTTLEMarketed from May 4, 2017

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 Ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 200 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 072096
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 70000-0176_ead9d7b1-1a6b-4b01-9c26-35b457c93eacSPL ID ead9d7b1-1a6b-4b01-9c26-35b457c93eacSPL set ID 63b8d389-7feb-41d2-8970-b7d5660ccb4aRxCUI 310965UNII WK2XYI10QM

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

N470000017601 followed by a unit qualifier and the quantity

Package 70000-0176-01. 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)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70000-0176

What is NDC 70000-0176?
70000-0176 is the product NDC for Leader Ibuprofen (ibuprofen), Ibuprofen 200 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 Ibuprofen (Ibuprofen).
What is the active ingredient?
Ibuprofen.
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 Ibuprofen?
5 other product NDCs are listed under this name. See all Leader Ibuprofen 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 Ibuprofen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
leader ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralCardinal Health 110, LLC. dba Leader70000-000370000-0003-0170000-0003-02
Leader IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCardinal Health 110, LLC. dba Leader70000-026270000-0262-01
Leader IbuprofenibuprofenIbuprofen 100 mg/1Tablet, ChewableOralCardinal Health 110, LLC. dba Leader70000-023970000-0239-01
leader IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCardinal Health 110, LLC. dba Leader70000-026470000-0264-01
Leader IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralCardinal Health 110, LLC. dba Leader70000-017570000-0175-0170000-0175-0270000-0175-03+3 more

Other NDCs under ANDA 072096

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

FDA NDC Directory listings under ANDA 072096
ProductStrengthForm · routeLabelerProduct NDC
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1911
Goodnow Pain ReliefibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralGobrands, Inc82501-0604
pain reliefibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralMeijer, Inc.79481-3000
up and up ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralTarget Corporation11673-604
good sense ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7249
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWalgreen Company0363-0604
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralMeijer Distribution Inc41250-647
foster and thrive ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1132
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralHyVee Inc42507-399
foster and thrive ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1136
MedlineiburprofenIbuprofen 200 mg/1Tablet, Film coatedOralMedline Industries, LP53329-603
Ibuprofen 250ibuprofenIbuprofen 200 mg/1Tablet, CoatedOralJHK Inc dba American Safety & First Aid73598-1104
good neighbor pharmacy ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen24385-604
IbuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-080
good neighbor pharmacy ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen24385-647
Ibuprofen 100ibuprofenIbuprofen 200 mg/1Tablet, CoatedOralJHK Inc dba American Safety & First Aid73598-1102
care one ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerican Sales Company41520-604
careone ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerican Sales Company41520-647
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5223
ibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-757

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