Over-the-counter drug · ANDA

Leader Childrens Ibuprofen (Ibuprofen) NDC 70000-0263

Ibuprofen 100 mg/5mL · Suspension · Oral · Cardinal Health 110, LLC. dba Leader

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0263Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0263Add 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
70000-0263-170000026301700000263011 BOTTLE in 1 CARTON (70000-0263-1) / 120 mL in 1 BOTTLEMarketed from Mar 28, 2017
70000-0263-270000026302700000263021 BOTTLE in 1 CARTON (70000-0263-2) / 240 mL in 1 BOTTLEMarketed from Mar 28, 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 Childrens Ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 100 mg/5mL
Dosage form
Suspension
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 074937
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 70000-0263_190f0279-7683-440a-aec8-7ee9445c1f9bSPL ID 190f0279-7683-440a-aec8-7ee9445c1f9bSPL set ID 913a4bd0-0784-45b4-b05e-3e7c016bbb86RxCUI 197803UNII 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

N470000026301 followed by a unit qualifier and the quantity

Package 70000-0263-01. 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 the common cold, flu, sore throat, headache and toothache • reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70000-0263

What is NDC 70000-0263?
70000-0263 is the product NDC for Leader Childrens Ibuprofen (ibuprofen), Ibuprofen 100 mg/5mL suspension, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Leader Childrens 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 Childrens Ibuprofen?
1 other product NDC are listed under this name. See all Leader Childrens 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 Childrens Ibuprofen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Leader Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCardinal Health 110, LLC. dba Leader70000-018170000-0181-01

Other NDCs under ANDA 074937

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

FDA NDC Directory listings under ANDA 074937
ProductStrengthForm · routeLabelerProduct NDC
childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralRite Aid Corporation11822-1685
equaline ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralUnited Natural Foods, Inc. dba UNFI41163-897
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralNuCare Pharmaceuticals, Inc.68071-5290
Good Neighbor Pharmacy Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmerisource Bergen24385-361
Good Neighbor Pharmacy Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmerisource Bergen24385-372
Rexall IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralDolgencorp, LLC55910-685
basic care childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmazon.com Services LLC72288-660
Good Sense Ibuprofen ChildrensibuprofenIbuprofen 100 mg/5mLSuspensionOralL. Perrigo Company0113-0660
childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralH E B37808-200
ibuprofen childrensibuprofenIbuprofen 100 mg/5mLSuspensionOralMeijer Distribution Inc41250-660
IbuprofenIbuprofen 100 mg/5mLSuspensionOralMajor Pharmaceuticals0904-5309
Leader IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCardinal Health 110, LLC. dba Leader70000-0262
Ibuprofen ChildrensibuprofenIbuprofen 100 mg/5mLSuspensionOralKroger Company30142-660
leader IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCardinal Health 110, LLC. dba Leader70000-0264
childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralMeijer Distribution Inc41250-685
basic care childrens ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmazon.com Services LLC72288-685
good neighbor pharmacy ibuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralAmerisource Bergen24385-905
ibuprofenIbuprofen 100 mg/5mLSuspensionOralNuCare Pharmaceuticals,Inc.68071-5315
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralSafeway21130-510
Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralSafeway21130-506

Showing 20 of 39.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in