Over-the-counter drug · ANDA

Dye Free Childrens Ibuprofen (ibuprofen) NDC 0121-1022

Ibuprofen 100 mg/5mL · Suspension · Oral · PAI Holdings, LLC dba PAI Pharma

NDC codes

FDA NDC Directory
Product NDC (as listed)0121-1022Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00121-1022Add 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
0121-1022-000012110220010 CUP, UNIT-DOSE in 1 CASE (0121-1022-00) / 5 mL in 1 CUP, UNIT-DOSEMarketed from Nov 3, 2023
0121-1022-050012110220510 CUP, UNIT-DOSE in 1 TRAY (0121-1022-05) / 5 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 — 100 mg/5mL
Dosage form
Suspension
Route
Oral
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 0121-1022_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

N400121102200 followed by a unit qualifier and the quantity

Package 00121-1022-00. 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)

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/5mLSuspensionOralDEMOULAS SUPERMARKETS INC.53942-119
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack63629-8851
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack63629-8852
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack63629-8853
Dolex ChildrenibuprofenIbuprofen 100 mg/100mLLiquidOralPharmadel LLC55758-304
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack63629-8540
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack72162-1910
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack72162-1909
Childrens Ibuprofen Oral Suspension, Bubble GumibuprofenIbuprofen 100 mg/5mLSuspensionOralBest Choice63941-127
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack72162-1911
Childrens Ibuprofen Oral Suspension, Dye FreeibuprofenIbuprofen 100 mg/5mLSuspensionOralBest Choice63941-128
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralBryant Ranch Prepack72162-1912
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralStrategic Sourcing Services70677-1116
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralStrategic Sourcing Services70677-1115
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralStrategic Sourcing Services70677-1117
Ibuprofen OralIbuprofen 100 mg/5mLSuspensionOralStrategic Sourcing Services70677-1118
Childrens Ibuprofen Oral SuspensionibuprofenIbuprofen 100 mg/5mLSuspensionOralDiscount Drug Mart53943-119
Childrens Ibuprofen Oral Suspension Dye FreeibuprofenIbuprofen 100 mg/5mLSuspensionOralFSA Store Inc. (Caring Mill)81522-311
Kosher MedsibuprofenIbuprofen 100 mg/5mLSuspensionOralMollec Inc82179-001
Kosher Meds Dye-Free IbuprofenibuprofenIbuprofen 100 mg/5mLSuspensionOralMollec Inc82179-006

Showing 20 of 39.

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