Over-the-counter drug · ANDA

Good Sense ibuprofen infants (Ibuprofen) NDC 0113-0057

Ibuprofen 50 mg/1.25mL · Suspension · Oral · L. Perrigo Company

NDC codes

FDA NDC Directory
Product NDC (as listed)0113-0057Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00113-0057Add 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
0113-0057-0500113005705001130057051 BOTTLE in 1 CARTON (0113-0057-05) / 15 mL in 1 BOTTLEMarketed from Feb 8, 2000

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Good Sense ibuprofen infantsSuffix: infants
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 50 mg/1.25mL
Dosage form
Suspension
Route
Oral
Labeler
L. Perrigo CompanyNDC labeler code 0113
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075217
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 0113-0057_99c7780e-159c-4da7-b22c-879c08458252SPL ID 99c7780e-159c-4da7-b22c-879c08458252SPL set ID c79e65e7-149b-450f-b083-99e16ff71729RxCUI 204442UNII 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

N400113005705 followed by a unit qualifier and the quantity

Package 00113-0057-05. 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: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0113-0057

What is NDC 0113-0057?
0113-0057 is the product NDC for Good Sense ibuprofen infants (ibuprofen), Ibuprofen 50 mg/1.25mL suspension, listed with the FDA by L. Perrigo Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Good Sense ibuprofen infants (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
L. Perrigo Company, NDC labeler code 0113. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Good Sense ibuprofen infants?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 075217

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

FDA NDC Directory listings under ANDA 075217
ProductStrengthForm · routeLabelerProduct NDC
basic care infants ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspensionOralAmazon.com Services LLC72288-057
basic care infants ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralAmazon.com Services LLC72288-255
care one ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralAmerican Sales Company41520-255
dg health ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralDolgencorp, LLC55910-255
Dg Health IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspensionOralDolgencorp, LLC55910-503
Equaline IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspensionOralUnited Natural Foods, Inc. dba UNFI41163-057
equaline ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralUnited Natural Foods, Inc. dba UNFI41163-255
Foster and Thrive IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralStrategic Sourcing Services LLC70677-1146
Foster and Thrive Infants IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspensionOralStrategic Sourcing Services LLC70677-1144
good neighbor pharmacy ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralAmerisource Bergen24385-550
Good Sense Infants IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralL. Perrigo Company0113-0040
ibuprofenIbuprofen 50 mg/1.25mLSuspensionOralMajor Pharmaceuticals0904-5463
ibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralRite Aid Corporation11822-0255
ibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralKroger Company30142-255
ibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralMeijer Distribution Inc41250-255
ibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralCVS Pharmacy59779-313
ibuprofen infantsibuprofenIbuprofen 50 mg/1.25mLSuspensionOralH E B37808-057
ibuprofen infantsibuprofenIbuprofen 50 mg/1.25mLSuspensionOralHyVee Inc42507-057
infants dye free ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralKroger Company30142-497
infants ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralWalgreen Company0363-8139

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