Over-the-counter drug · ANDA
Ibuprofen NDC 83059-0049
Ibuprofen 200 mg/1 · Tablet, Coated · Oral · Shield Pharmaceuticals Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83059-0049-3 | 8305900490383059004903 | 1 BOTTLE in 1 CARTON (83059-0049-3) / 30 TABLET, COATED in 1 BOTTLEMarketed from Oct 8, 2024 |
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 CorpNDC labeler code 83059
- 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 83059-0049_58616ecb-a36e-3a89-e063-6294a90a3293SPL ID 58616ecb-a36e-3a89-e063-6294a90a3293SPL set ID 216e5600-56b4-44b0-88b7-69adfb245802RxCUI 310965UNII 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
N483059004903followed by a unit qualifier and the quantityPackage 83059-0049-03. 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.
About NDC 83059-0049
- What is NDC 83059-0049?
- 83059-0049 is the product NDC for Ibuprofen, Ibuprofen 200 mg/1 tablet, coated, listed with the FDA by Shield Pharmaceuticals Corp. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibuprofen.
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Shield Pharmaceuticals Corp, NDC labeler code 83059. 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?
- 674 other product NDCs are listed under this name. See all Ibuprofen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ibuprofen 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 | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4784 | 70518-4784-0070518-4784-01 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4786 | 70518-4786-00 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Famora Inc | 87509-0004 | 87509-0004-05 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-724 | 82461-0724-90 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-725 | 82461-0725-90 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Aurohealth LLC | 58602-913 | 58602-0913-1758602-0913-40 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-737 | 67877-0737-0167877-0737-0567877-0737-33+1 more |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-738 | 67877-0738-0167877-0738-0567877-0738-30+3 more |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-739 | 67877-0739-0167877-0739-0567877-0739-30+4 more |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | GOODSENSE | 50804-185 | 50804-0185-0150804-0185-02 |
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 | TabletOral | PROSTAT FIRST AID | 58228-6185 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Allegiant Health | 69168-466 |
| 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 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Shield Pharmaceuticals Corp | 83059-0165 |
| Ibuprofen 200mg | Ibuprofen 200 mg/1 | TabletOral | Allegiant Health | 69168-467 |