Over-the-counter drug · ANDA
Ibuprofen NDC 58602-801
Ibuprofen 200 mg/1 · Tablet · Oral · Aurohealth LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-801-07 | 58602080107 | 1 BOTTLE in 1 CARTON (58602-801-07) / 24 TABLET in 1 BOTTLEMarketed from Nov 8, 2017 | |
| 58602-801-12 | 58602080112 | 1 BOTTLE in 1 CARTON (58602-801-12) / 40 TABLET in 1 BOTTLEMarketed from Nov 8, 2017 | |
| 58602-801-14 | 58602080114 | 1 BOTTLE in 1 CARTON (58602-801-14) / 50 TABLET in 1 BOTTLEMarketed from Nov 8, 2017 | |
| 58602-801-15 | 58602080115 | 1 BOTTLE in 1 CARTON (58602-801-15) / 60 TABLET in 1 BOTTLEMarketed from Nov 8, 2017 | |
| 58602-801-19 | 58602080119 | 1 BOTTLE in 1 CARTON (58602-801-19) / 90 TABLET in 1 BOTTLEMarketed from Nov 8, 2017 | |
| 58602-801-21 | 58602080121 | 1 BOTTLE in 1 CARTON (58602-801-21) / 100 TABLET in 1 BOTTLEMarketed from Nov 8, 2017 | |
| 58602-801-29 | 58602080129 | 1 BOTTLE in 1 CARTON (58602-801-29) / 150 TABLET in 1 BOTTLEMarketed from Nov 8, 2017 | |
| 58602-801-34 | 58602080134 | 1 BOTTLE in 1 CARTON (58602-801-34) / 200 TABLET in 1 BOTTLEMarketed from Nov 8, 2017 | |
| 58602-801-35 | 58602080135 | 1 BOTTLE in 1 CARTON (58602-801-35) / 225 TABLET in 1 BOTTLEMarketed from Nov 8, 2017 | |
| 58602-801-36 | 58602080136 | 1 BOTTLE in 1 CARTON (58602-801-36) / 250 TABLET in 1 BOTTLEMarketed from Nov 8, 2017 | |
| 58602-801-38 | 58602080138 | 300 TABLET in 1 BOTTLE (58602-801-38)Marketed from Nov 8, 2017 | |
| 58602-801-40 | 58602080140 | 500 TABLET in 1 BOTTLE (58602-801-40)Marketed from Nov 8, 2017 | |
| 58602-801-41 | 58602080141 | 1000 TABLET in 1 BOTTLE (58602-801-41)Marketed from Nov 8, 2017 | |
| 58602-801-59 | 58602080159 | 1500 TABLET in 1 BOTTLE (58602-801-59)Marketed from Nov 8, 2017 | |
| 58602-801-87 | 58602080187 | 550 TABLET in 1 BOTTLE (58602-801-87)Marketed from Nov 8, 2017 | |
| 58602-801-88 | 58602080188 | 750 TABLET in 1 BOTTLE (58602-801-88)Marketed from Nov 8, 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
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurohealth LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208865
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 58602-801_19309ddd-73dc-462a-afaa-899834a2d783SPL ID 19309ddd-73dc-462a-afaa-899834a2d783SPL set ID 0ade8ee2-7c74-4b05-925e-d92742fc2b90RxCUI 310965UNII WK2XYI10QMUPC 0358602801212
- 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
N458602080107followed by a unit qualifier and the quantityPackage 58602-0801-07. 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 muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208865
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 | TabletOral | Aurohealth LLC | 58602-708 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Aurohealth LLC | 58602-713 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Aurohealth LLC | 58602-802 |
| Amazon Basic Care Ibuprofenibuprofen | Ibuprofen 200 mg/1 | TabletOral | Amazon.com Services LLC | 72288-513 |