Over-the-counter drug · ANDA
Ibuprofen NDC 49483-611
Ibuprofen 200 mg/1 · Tablet, Film coated · Oral · TIME CAP LABORATORIES,INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-611-00 | 49483061100 | 6500 TABLET, FILM COATED in 1 BAG (49483-611-00)Marketed from Nov 16, 2016 | |
| 49483-611-01 | 49483061101 | 100 TABLET, FILM COATED in 1 BOTTLE (49483-611-01)Marketed from Nov 16, 2016 | |
| 49483-611-05 | 49483061105 | 50 TABLET, FILM COATED in 1 BOTTLE (49483-611-05)Marketed from Nov 16, 2016 |
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, Film coated
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES,INC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091237
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 49483-611_20b8a0bc-778a-7848-e063-6394a90ad512SPL ID 20b8a0bc-778a-7848-e063-6394a90ad512SPL set ID 82aad715-f652-471b-840c-5151c66e5adeRxCUI 310965UNII WK2XYI10QMUPC 0349483612349
- 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
N449483061100followed by a unit qualifier and the quantityPackage 49483-0611-00. 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 pain 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 091237
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 | CARDINAL HEALTH | 70000-0597 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | WALGREENS | 0363-9611 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | CVS Pharmacy.Inc. | 69842-489 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | WALGREENS | 0363-9612 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | CVS Pharmacy. Inc. | 69842-493 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-135 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-136 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | TARGET CORPORATION | 11673-993 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | RITE AID | 11822-7893 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | RITE AID | 11822-8925 |
| Ibuprofenibuprofen tablets usp, 200mg | Ibuprofen 200 mg/1 | TabletOral | KROGER COMPANY | 41226-612 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | TIME CAP LABORATORIES,INC | 49483-612 |
| Ibuprofenibuprofen tablets usp, 200mg | Ibuprofen 200 mg/1 | TabletOral | BETTER LIVING BRANDS, LLC | 21130-992 |