Over-the-counter drug · ANDA
Ibuprofen and Pseudoephedrine Hydrochloride NDC 58602-839
Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 · Tablet, Coated · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-839-13 | 58602083913 | 4 BLISTER PACK in 1 CARTON (58602-839-13) / 8 TABLET, COATED in 1 BLISTER PACKMarketed from Mar 10, 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)
- Ibuprofen and Pseudoephedrine Hydrochloride
- Generic name (nonproprietary)
- ibuprofen and pseudoephedrine hydrochloride
- Active ingredients
- Ibuprofen — 200 mg/1Pseudoephedrine hydrochloride — 30 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Aurohealth LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213565
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 58602-839_8c55a203-6e1b-4f5b-9788-cde24942b6dfSPL ID 8c55a203-6e1b-4f5b-9788-cde24942b6dfSPL set ID c01116d3-32f8-41f0-8e31-c4142265ef56RxCUI 1299021UNII WK2XYI10QM, 6V9V2RYJ8N
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug; alpha-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
N458602083913followed by a unit qualifier and the quantityPackage 58602-0839-13. 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
Excerpt only. Read the full label for complete information.