Prescription drug · ANDA
Ibuprofen NDC 83008-050
Ibuprofen 800 mg/1 · Tablet · Oral · Quality Care Products, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83008-050-30 | 8300800503083008005030 | 30 TABLET in 1 BOTTLE (83008-050-30)Marketed from Feb 8, 2024 | |
| 83008-050-60 | 8300800506083008005060 | 60 TABLET in 1 BOTTLE (83008-050-60)Marketed from Jan 17, 2024 | |
| 83008-050-90 | 8300800509083008005090 | 90 TABLET in 1 BOTTLE (83008-050-90)Marketed from Jan 17, 2024 |
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 — 800 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Quality Care Products, LLCNDC labeler code 83008
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213794
- Marketing start
- Marketing end
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 83008-050_2e81f4ce-5303-42fb-bb01-982044a6b3faSPL ID 2e81f4ce-5303-42fb-bb01-982044a6b3faSPL set ID 246b120e-3458-4721-bf95-82537feaa131RxCUI 197807UNII 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
N483008005030followed by a unit qualifier and the quantityPackage 83008-0050-30. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 83008-050
- What is NDC 83008-050?
- 83008-050 is the product NDC for Ibuprofen, Ibuprofen 800 mg/1 tablet, listed with the FDA by Quality Care Products, LLC. It has 3 package NDCs, 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?
- Quality Care Products, LLC, NDC labeler code 83008. 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 800 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-725 | 82461-0725-90 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-724 | 82461-0724-90 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Aurohealth LLC | 58602-913 | 58602-0913-1758602-0913-40 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-738 | 67877-0738-0167877-0738-0567877-0738-30+3 more |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-737 | 67877-0737-0167877-0737-0567877-0737-33+1 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 213794
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 600 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2998 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | A-S Medication Solutions | 50090-5433 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-5444 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | A-S Medication Solutions | 50090-5435 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Direct_Rx | 72189-556 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Proficient Rx LP | 82804-293 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-045 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-5446 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2947 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-5445 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0424 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Direct_rx | 72189-564 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-362 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Sportpharm LLC | 85766-218 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Sportpharm LLC | 85766-219 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-360 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Sportpharm LLC | 85766-220 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-361 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Proficient Rx LP | 82804-320 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Quality Care Products, LLC | 83008-066 |
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