Over-the-counter drug · ANDA

CounterAct IB (Ibuprofen) NDC 54473-306

Ibuprofen 200 mg/1 · Tablet, Coated · Oral · Melaleuca, Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)54473-306Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54473-0306Add 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
54473-306-5054473030650544730306501 BOTTLE in 1 BOX (54473-306-50) / 50 TABLET, COATED in 1 BOTTLEMarketed from Aug 14, 2023

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)
CounterAct IBSuffix: IB
Generic name (nonproprietary)
ibuprofen
Active ingredients
Ibuprofen — 200 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
Melaleuca, IncNDC labeler code 54473
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 072096
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 54473-306_4d4001f1-0e22-4f9a-e063-6394a90ae123SPL ID 4d4001f1-0e22-4f9a-e063-6394a90ae123SPL set ID 7fafc13e-3fee-ace3-e053-2a91aa0ac2eaRxCUI 310965, 1101919UNII 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

N454473030650 followed by a unit qualifier and the quantity

Package 54473-0306-50. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Uses temporarily relieves minor aches and pains due to: backache headache menstrual cramps minor pain of arthritis muscular aches the common cold toothache temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54473-306

What is NDC 54473-306?
54473-306 is the product NDC for CounterAct IB (ibuprofen), Ibuprofen 200 mg/1 tablet, coated, listed with the FDA by Melaleuca, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
CounterAct IB (Ibuprofen).
What is the active ingredient?
Ibuprofen.
Who is the labeler?
Melaleuca, Inc, NDC labeler code 54473. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for CounterAct IB?
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 072096

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

FDA NDC Directory listings under ANDA 072096
ProductStrengthForm · routeLabelerProduct NDC
365 whole foods market ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWhole Foods Market, INC.42681-0026
basic care ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-311
basic care ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-604
Berkley and Jensen IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralBJWC68391-604
betr pain reliefibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLive Betr LLC80267-604
betr remedies ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralLive Betr LLC80267-999
care one ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerican Sales Company41520-604
careone ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerican Sales Company41520-647
dg health ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralDolgencorp, LLC55910-604
dg health ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralDolgencorp Inc55910-647
equaline ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralUnited Natural Foods, Inc. dba UNFI41163-604
equaline ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralUnited Natural Foods, Inc. dba UNFI41163-647
Equate IbuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-553
equate ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-604
equate ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralWal-Mart Stores Inc49035-647
foster and thrive ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1132
foster and thrive ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralStrategic Sourcing Services LLC70677-1136
good neighbor pharmacy ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen24385-604
good neighbor pharmacy ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen24385-647
Good neighbor pharmacy ibuprofenibuprofenIbuprofen 200 mg/1Tablet, Film coatedOralAmerisource Bergen46122-548

Showing 20 of 39.

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