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| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54473-306-50 | 5447303065054473030650 | 1 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
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N454473030650followed by a unit qualifier and the quantityPackage 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.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| up and up ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Target Corporation | 11673-604 |
| ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-043 |
| Topcare Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-647 |
| good sense ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-0647 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Rite Aid Corporation | 11822-6604 |
| Berkley and Jensen Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | BJWC | 68391-604 |
| ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-787 |
| ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-0604 |
| basic care ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-311 |
| ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6747 |
| Signature Care Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Safeway | 21130-818 |
| ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | H E B | 37808-647 |
| equaline ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | United Natural Foods, Inc. dba UNFI | 41163-604 |
| kirkland signature ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Costco Wholesale Company | 63981-604 |
| ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-191 |
| equaline ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | United Natural Foods, Inc. dba UNFI | 41163-647 |
| good sense ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2047 |
| good sense ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8590 |
| ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7912 |
| Good neighbor pharmacy ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Amerisource Bergen | 46122-548 |
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