Over-the-counter drug · ANDA

infants ibuprofen (Ibuprofen) NDC 37808-255

Ibuprofen 50 mg/1.25mL · Suspension/ drops · Oral · H E B

NDC codes

FDA NDC Directory
Product NDC (as listed)37808-255Labeler and product segments. Claims need a package NDC.
Product NDC at billing width37808-0255Add 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
37808-255-10378080255101 BOTTLE in 1 CARTON (37808-255-10) / 30 mL in 1 BOTTLEMarketed from Feb 25, 2005

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
infants ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 50 mg/1.25mL
Dosage form
Suspension/ drops
Route
Oral
Labeler
H E BNDC labeler code 37808
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 37808-255_edea0019-eee0-4c6e-aafb-f8854d012b74SPL ID edea0019-eee0-4c6e-aafb-f8854d012b74SPL set ID 2c67fecb-2e69-44d6-8ab8-3251abae72a6RxCUI 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

N437808025510 followed by a unit qualifier and the quantity

Package 37808-0255-10. 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 37808-255

What is NDC 37808-255?
37808-255 is the product NDC for infants ibuprofen (ibuprofen), Ibuprofen 50 mg/1.25mL suspension/ drops, listed with the FDA by H E B. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
infants ibuprofen (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
H E B, NDC labeler code 37808. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for infants ibuprofen?
6 other product NDCs are listed under this name. See all infants 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 infants ibuprofen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Infants IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralAmazon.com Services LLC72288-77072288-0770-10
Infants IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralSafeway21130-51321130-0513-10
Infants IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspensionOralAurohealth LLC58602-22758602-0227-0458602-0227-07
Infants IbuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralFamily Dollar Services, Inc.55319-63755319-0637-09
infants ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralWalgreen Company0363-813900363-8139-10
Infants IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspensionOralWalgreens0363-510000363-5100-01

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 ibuprofen infantsibuprofenIbuprofen 50 mg/1.25mLSuspensionOralL. Perrigo Company0113-0057
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

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