Prescription drug · ANDA
Ibuprofen NDC 51655-474
Ibuprofen 600 mg/1 · Tablet, Film coated · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-474-20 | 5165504742051655047420 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-474-20)Marketed from Nov 19, 2020 | |
| 51655-474-25 | 5165504742551655047425 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-474-25)Marketed from Nov 13, 2020 | |
| 51655-474-26 | 5165504742651655047426 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-474-26)Marketed from Jun 21, 2022 | |
| 51655-474-51 | 5165504745151655047451 | 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-474-51)Marketed from Feb 8, 2021 | |
| 51655-474-52 | 5165504745251655047452 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-474-52)Marketed from Jan 14, 2021 |
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 — 600 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Northwind Health Company, LLCNDC labeler code 51655
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090796
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 51655-474_490f163b-b179-d74b-e063-6394a90ad438SPL ID 490f163b-b179-d74b-e063-6394a90ad438SPL set ID dac07d8f-6b6f-20ab-e053-2a95a90af3baRxCUI 197806UNII 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
N451655047420followed by a unit qualifier and the quantityPackage 51655-0474-20. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.
Excerpt only. Read the full label for complete information.
About NDC 51655-474
- What is NDC 51655-474?
- 51655-474 is the product NDC for Ibuprofen, Ibuprofen 600 mg/1 tablet, film coated, listed with the FDA by Northwind Health Company, LLC. It has 5 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?
- Northwind Health Company, LLC, NDC labeler code 51655. 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?
- 672 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 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4801 | 70518-4801-00 |
| 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 |
Other NDCs under ANDA 090796
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 | Tablet, Film coatedOral | DIRECT RX | 72189-231 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-123 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0426 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-121 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-122 |
| ibuprofen | Ibuprofen 400 mg/1 | TabletOral | SKYA HEALTH, LLC | 73086-210 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | DIRECT RX | 72189-266 |
| ibuprofen | Ibuprofen 600 mg/1 | TabletOral | SKYA HEALTH, LLC | 73086-211 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-604 |
| ibuprofen | Ibuprofen 800 mg/1 | TabletOral | SKYA HEALTH, LLC | 73086-212 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4459 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5126 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5135 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5134 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5140 |
| Ibuprofen | Ibuprofen 400 mg/1 | Tablet, Film coatedOral | Direct Rx | 72189-324 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0243 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-097 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1396 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3313 |
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