Over-the-counter drug · ANDA
Congestion Relief NDC 41250-158
ibuprofen, phenylephrine hcl · Ibuprofen 200 mg/1; Phenylephrine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Meijer Distribution Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41250-158-60 | 41250015860 | 20 BLISTER PACK in 1 CARTON (41250-158-60) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 17, 2014 |
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)
- Congestion Relief
- Generic name (nonproprietary)
- ibuprofen, phenylephrine hcl
- Active ingredients
- Ibuprofen — 200 mg/1Phenylephrine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Meijer Distribution Inc
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203200
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 41250-158_d7794f31-7ab8-4ca1-b01b-87b955d012e2SPL ID d7794f31-7ab8-4ca1-b01b-87b955d012e2SPL set ID 84f932b6-0aee-4cf9-b4b9-213560c42c1dRxCUI 1369775UNII WK2XYI10QM, 04JA59TNSJ
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug; alpha-1 Adrenergic Agonist
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
N441250015860followed by a unit qualifier and the quantityPackage 41250-0158-60. 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 these symptoms associated with the common cold or flu: • headache • fever • sinus pressure • nasal congestion • minor body aches and pains • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203200
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 |
|---|---|---|---|---|
| Equaline congestion reliefibuprofen, phenylephrine hcl | Ibuprofen 200 mg/1; Phenylephrine hydrochloride 10 mg/1 | Tablet, Film coatedOral | United Natural Foods, Inc. dba UNFI | 41163-158 |
| Sudafed PE Head Congestion Plus Painibuprofen and phenylephrine hydrochloride | Ibuprofen 200 mg/1; Phenylephrine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-436 |