Over-the-counter drug · ANDA

Dye Free Childrens Ibuprofen (Ibuprofen) NDC 0121-2044

Ibuprofen 200 mg/10mL · Suspension · Oral · PAI Holdings, LLC dba PAI Pharma

NDC codes

FDA NDC Directory
Product NDC (as listed)0121-2044Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00121-2044Add 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
0121-2044-000012120440010 CUP, UNIT-DOSE in 1 CASE (0121-2044-00) / 10 mL in 1 CUP, UNIT-DOSEMarketed from Nov 3, 2023
0121-2044-100012120441010 CUP, UNIT-DOSE in 1 TRAY (0121-2044-10) / 10 mL in 1 CUP, UNIT-DOSEMarketed from Nov 3, 2023

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)
Dye Free Childrens Ibuprofen
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 200 mg/10mL
Dosage form
Suspension
Route
Oral
Labeler
PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210602
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 0121-2044_d1635350-9966-4795-9bc2-6cf2b690eaecSPL ID d1635350-9966-4795-9bc2-6cf2b690eaecSPL set ID a616a7cd-4814-478e-8c58-7fbc2454d992RxCUI 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

N400121204400 followed by a unit qualifier and the quantity

Package 00121-2044-00. 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 0121-2044

What is NDC 0121-2044?
0121-2044 is the product NDC for Dye Free Childrens Ibuprofen (ibuprofen), Ibuprofen 200 mg/10mL suspension, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dye Free Childrens Ibuprofen (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dye Free Childrens Ibuprofen?
3 other product NDCs are listed under this name. See all Dye Free 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 Dye Free Childrens Ibuprofen NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Dye Free Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralCVS51316-91451316-0914-03
Dye Free Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralPAI Holdings, LLC dba PAI Pharma0121-102200121-1022-0000121-1022-05
Dye Free Childrens IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralPrecision Dose Inc.68094-60068094-0600-6168094-0600-62

Other NDCs under ANDA 210602

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

FDA NDC Directory listings under ANDA 210602
ProductStrengthForm · routeLabelerProduct NDC
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralDiscount Drug Mart53943-119
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralStrategic Sourcing Services70677-1118
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralStrategic Sourcing Services70677-1115
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralStrategic Sourcing Services70677-1116
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralStrategic Sourcing Services70677-1117
Childrens Ibuprofen Oral Suspension Dye FreeibuprofenIbuprofen 100 mg/5mLSuspensionOralFSA Store Inc. (Caring Mill)81522-311
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack72162-1909
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack72162-1910
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack72162-1911
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack72162-1912
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack63629-8540
Childrens Ibuprofen Oral Suspension, Bubble GumibuprofenIbuprofen 100 mg/5mLSuspensionOralBest Choice63941-127
Childrens Ibuprofen Oral Suspension, Dye FreeibuprofenIbuprofen 100 mg/5mLSuspensionOralBest Choice63941-128
Kosher MedsibuprofenIbuprofen 100 mg/5mLSuspensionOralMollec Inc82179-001
Kosher Meds Dye-Free IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralMollec Inc82179-006
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralMarc Glassman, Inc.68998-320
Pediacare Childrens Ibuprofen BerryibuprofenIbuprofen 100 mg/5mLSuspensionOralRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH52412-910
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralCamber Consumer Care Inc69230-310
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralCamber Consumer Care Inc69230-308
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralCamber Consumer Care Inc69230-309

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