Over-the-counter drug · ANDA

up and up dye free infants concentrated ibuprofen (Ibuprofen) NDC 11673-255

Ibuprofen 50 mg/1.25mL · Suspension/ drops · Oral · Target Corporation

NDC codes

FDA NDC Directory
Product NDC (as listed)11673-255Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11673-0255Add 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
11673-255-1011673025510116730255101 BOTTLE in 1 CARTON (11673-255-10) / 30 mL in 1 BOTTLEMarketed from Jul 8, 2009
11673-255-1611673025516116730255162 BOTTLE in 1 CARTON (11673-255-16) / 30 mL in 1 BOTTLEMarketed from Aug 23, 2018

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

Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 50 mg/1.25mL
Dosage form
Suspension/ drops
Route
Oral
Labeler
Target CorporationNDC labeler code 11673
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 11673-255_7a7cb2f6-5a1e-4ee5-b81e-bd68fdc278f6SPL ID 7a7cb2f6-5a1e-4ee5-b81e-bd68fdc278f6

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

N411673025510 followed by a unit qualifier and the quantity

Package 11673-0255-10. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 11673-255

What is NDC 11673-255?
11673-255 is the product NDC for up and up dye free infants concentrated ibuprofen, Ibuprofen 50 mg/1.25mL suspension/ drops, listed with the FDA by Target Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
up and up dye free infants concentrated ibuprofen (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Target Corporation, NDC labeler code 11673. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for up and up dye free infants concentrated ibuprofen?
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
equaline ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralUnited Natural Foods, Inc. dba UNFI41163-255
basic care infants ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralAmazon.com Services LLC72288-255
Topcare Infants IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspensionOralTopco Associates LLC36800-057
ibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralKroger Company30142-255
ibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralCVS Pharmacy59779-313
ibuprofen infantsibuprofenIbuprofen 50 mg/1.25mLSuspensionOralH E B37808-057
Dg Health IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspensionOralDolgencorp, LLC55910-503
ibuprofen infantsibuprofenIbuprofen 50 mg/1.25mLSuspensionOralHyVee Inc42507-057
Topcare IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralTopco Associates LLC36800-255
profen ib infantsibuprofenIbuprofen 50 mg/1.25mLSuspensionOralPublix Super Markets Inc56062-057
infants dye free ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralKroger Company30142-497
ibuprofenIbuprofen 50 mg/1.25mLSuspensionOralMajor Pharmaceuticals0904-5463
Good Sense Infants IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralL. Perrigo Company0113-0040
care one ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralAmerican Sales Company41520-255
infants ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralWalgreen Company0363-8139
profen ibibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralPublix Super Markets Inc56062-404
good neighbor pharmacy ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralAmerisource Bergen24385-550
infants ibuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralH E B37808-255
Good Sense ibuprofen infantsibuprofenIbuprofen 50 mg/1.25mLSuspensionOralL. Perrigo Company0113-0057
Infants IbuprofenibuprofenIbuprofen 50 mg/1.25mLSuspension/ dropsOralSafeway21130-513

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