Over-the-counter drug · ANDA
Ibuprofen NDC 83059-0165
Ibuprofen 200 mg/1 · Tablet, Coated · Oral · Shield Pharmaceuticals Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83059-0165-3 | 83059016503 | 1 BOTTLE in 1 CARTON (83059-0165-3) / 30 TABLET, COATED in 1 BOTTLEMarketed from Jul 24, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Coated
- Route
- Oral
- Labeler
- Shield Pharmaceuticals Corp
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207095
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 83059-0165_575dbcb4-5dfe-a2b6-e063-6294a90a24b5SPL ID 575dbcb4-5dfe-a2b6-e063-6294a90a24b5SPL set ID 1ca722bb-940e-4b3e-9561-d87e2feb1ff8RxCUI 310965UNII WK2XYI10QMUPC 0611419406125
- 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
N483059016503followed by a unit qualifier and the quantityPackage 83059-0165-03. 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 minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207095
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 | Tablet, CoatedOral | Shield Pharmaceuticals Corp | 83059-0049 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | PROSTAT FIRST AID | 58228-6185 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Allegiant Health | 69168-466 |
| Ibuprofen 200mg | Ibuprofen 200 mg/1 | TabletOral | Allegiant Health | 69168-467 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Trifecta Pharmaceuticals USA LLC | 69396-141 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Trifecta Pharmaceuticals USA LLC | 69396-145 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Trifecta Pharmaceuticals USA LLC | 69396-172 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Shield Pharmaceuticals Corp | 83059-0020 |