Over-the-counter drug · ANDA
Ibuprofen NDC 58602-879
Ibuprofen 200 mg/1 · Capsule · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-879-38 | 58602087938 | 300 CAPSULE in 1 BOTTLE (58602-879-38)Marketed from Sep 6, 2022 |
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
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurohealth LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207753
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 58602-879_e1b49257-d226-457f-8f2d-9a757a65bbcbSPL ID e1b49257-d226-457f-8f2d-9a757a65bbcbSPL set ID e1b49257-d226-457f-8f2d-9a757a65bbcbRxCUI 310964UNII 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
N458602087938followed by a unit qualifier and the quantityPackage 58602-0879-38. 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 minor aches and pains due to: headache toothache backache menstrual cramps muscular aches the common cold minor pain of arthritis temporarily reduces fever
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207753
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 | Ibuprofen 200 mg/1 | CapsuleOral | RITE AID CORPORATION | 11822-4258 |
| Ibuprofen | Ibuprofen 200 mg/1 | CapsuleOral | Better Living Brands LLC | 21130-032 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-046 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | P & L Development, LLC | 59726-046 |
| Ibuprofen | Ibuprofen 200 mg/1 | CapsuleOral | Aurohealth LLC | 58602-843 |
| Ibuprofen | Ibuprofen 200 mg/1 | CapsuleOral | Aurohealth LLC | 58602-852 |
| Ibuprofen | Ibuprofen 200 mg/1 | CapsuleOral | Aurohealth LLC | 58602-902 |