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
70000-0176-1700000176011 BOTTLE in 1 CARTON (70000-0176-1) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Nov 30, 2016
70000-0176-4700000176041 BOTTLE in 1 CARTON (70000-0176-4) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from May 4, 2017
70000-0176-5700000176051 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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
365 whole foods market ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWhole Foods Market, INC.42681-0026
basic care ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-311
basic care ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-604
Berkley and Jensen IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralBJWC68391-604
betr pain reliefibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLive Betr LLC80267-604
betr remedies ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLive Betr LLC80267-999
care one ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerican Sales Company41520-604
careone ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerican Sales Company41520-647
CounterAct IBibuprofenIbuprofen 200 mg/1Tablet, CoatedOralMelaleuca, Inc54473-306
dg health ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralDolgencorp, LLC55910-604
dg health ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralDolgencorp Inc55910-647
equaline ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralUnited Natural Foods, Inc. dba UNFI41163-604
equaline ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralUnited Natural Foods, Inc. dba UNFI41163-647
Equate IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-553
equate ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-604
equate ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-647
foster and thrive ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1132
foster and thrive ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1136
good neighbor pharmacy ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen24385-604
good neighbor pharmacy ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen24385-647

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