Over-the-counter drug · ANDA
Ibuprofen and Pseudoephedrine HCl NDC 58602-803
Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 · Capsule, Liquid filled · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-803-03 | 58602080303 | 1 BLISTER PACK in 1 CARTON (58602-803-03) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83)Marketed from Jan 17, 2020 | |
| 58602-803-08 | 58602080308 | 4 BLISTER PACK in 1 CARTON (58602-803-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83)Marketed from Dec 1, 2017 | |
| 58602-803-13 | 58602080313 | 4 BLISTER PACK in 1 CARTON (58602-803-13) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-79)Marketed from Dec 1, 2017 | |
| 58602-803-67 | 58602080367 | 2 BLISTER PACK in 1 CARTON (58602-803-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83)Marketed from Dec 1, 2017 |
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 HCl
- Generic name (nonproprietary)
- ibuprofen and pseudoephedrine hcl
- Active ingredients
- Ibuprofen — 200 mg/1Pseudoephedrine hydrochloride — 30 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Aurohealth LLCNDC labeler code 58602
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209235
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 58602-803_08c50304-67d6-4733-84e4-5a686afa04f3SPL ID 08c50304-67d6-4733-84e4-5a686afa04f3SPL set ID 6adf9292-b4af-4cb4-99f3-dda03734570aRxCUI 1299018UNII 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
N458602080303followed by a unit qualifier and the quantityPackage 58602-0803-03. 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 sinus pressure nasal congestion minor body aches and pains fever
Excerpt only. Read the full label for complete information.
About NDC 58602-803
- What is NDC 58602-803?
- 58602-803 is the product NDC for Ibuprofen and Pseudoephedrine HCl, Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 capsule, liquid filled, listed with the FDA by Aurohealth LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibuprofen and Pseudoephedrine HCl.
- What is the active ingredient?
- Ibuprofen, Pseudoephedrine hydrochloride.
- Who is the labeler?
- Aurohealth LLC, NDC labeler code 58602. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ibuprofen and Pseudoephedrine HCl?
- 4 other product NDCs are listed under this name. See all Ibuprofen and Pseudoephedrine HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ibuprofen and Pseudoephedrine HCl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ibuprofen and Pseudoephedrine HCl | Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 | Capsule, Liquid filledOral | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0606 | 70000-0606-0170000-0606-02 |
| Ibuprofen and Pseudoephedrine HCl | Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 | Capsule, Liquid filledOral | WALGREEN CO. | 0363-1106 | 00363-1106-0800363-1106-67 |
| Ibuprofen and Pseudoephedrine HCl | Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 | Capsule, Liquid filledOral | Amerisource Bergen | 46122-609 | 46122-0609-58 |
| Ibuprofen and Pseudoephedrine HCl | Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 | Capsule, Liquid filledOral | CVS Pharmacy, Inc. | 69842-092 | 69842-0092-1369842-0092-67 |
Other NDCs under ANDA 209235
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 |
|---|---|---|---|---|
| Ibuprofen and Pseudoephedrine HCl | Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 | Capsule, Liquid filledOral | WALGREEN CO. | 0363-1106 |
| Ibuprofen and Pseudoephedrine HCl | Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 | Capsule, Liquid filledOral | Amerisource Bergen | 46122-609 |
| Ibuprofen and Pseudoephedrine HCl | Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 | Capsule, Liquid filledOral | CVS Pharmacy, Inc. | 69842-092 |
| Ibuprofen and Pseudoephedrine HCl | Ibuprofen 200 mg/1; Pseudoephedrine hydrochloride 30 mg/1 | Capsule, Liquid filledOral | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0606 |