Prescription drug · ANDA
Ibu (Ibuprofen) NDC 68071-3053
Ibuprofen 800 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3053-0 | 6807130530068071305300 | 12 TABLET in 1 BOTTLE (68071-3053-0)Marketed from Mar 16, 2018 | |
| 68071-3053-1 | 6807130530168071305301 | 120 TABLET in 1 BOTTLE (68071-3053-1)Marketed from Mar 16, 2018 | |
| 68071-3053-2 | 6807130530268071305302 | 20 TABLET in 1 BOTTLE (68071-3053-2)Marketed from Mar 16, 2018 | |
| 68071-3053-4 | 6807130530468071305304 | 40 TABLET in 1 BOTTLE (68071-3053-4)Marketed from Mar 16, 2018 | |
| 68071-3053-6 | 6807130530668071305306 | 60 TABLET in 1 BOTTLE (68071-3053-6)Marketed from Mar 16, 2018 |
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)
- Ibu
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 800 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075682
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-3053_1d8e3521-5b6d-3418-e063-6294a90a9c41SPL ID 1d8e3521-5b6d-3418-e063-6294a90a9c41SPL set ID 678e2d16-33f3-67a7-e053-2991aa0a1132RxCUI 197807, 206917UNII WK2XYI10QMUPC 0368071305333
- 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
N468071305300followed by a unit qualifier and the quantityPackage 68071-3053-00. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS ). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.
Excerpt only. Read the full label for complete information.
About NDC 68071-3053
- What is NDC 68071-3053?
- 68071-3053 is the product NDC for Ibu (ibuprofen), Ibuprofen 800 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibu (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ibu?
- 10 other product NDCs are listed under this name. See all Ibu NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ibu products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ibuibuprofen | Ibuprofen 600 mg/1 | TabletOral | Proficient Rx LP | 63187-614 | 63187-0614-1563187-0614-2063187-0614-21+7 more |
| Ibuibuprofen | Ibuprofen 800 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-963 | 66267-0963-00 |
| Ibuibuprofen | Ibuprofen 600 mg/1 | TabletOral | NuCare Pharmaceuticals Inc. | 66267-964 | 66267-0964-00 |
| Ibu | Ibuprofen 600 mg/1 | TabletOral | RedPharm Drug, Inc. | 67296-0913 | 67296-0913-0167296-0913-0367296-0913-09 |
| Ibuibuprofen | Ibuprofen 400 mg/1 | TabletOral | Proficient Rx LP | 71205-604 | 71205-0604-1571205-0604-2071205-0604-21+4 more |
| Ibuibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-275 | 71610-0275-6071610-0275-8071610-0275-92 |
| Ibuibuprofen | Ibuprofen 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-501 | 71610-0501-6071610-0501-8071610-0501-92 |
| Ibuibuprofen | Ibuprofen 400 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-369 | 51407-0369-05 |
| Ibuibuprofen | Ibuprofen 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-547 | 71610-0547-6071610-0547-8071610-0547-92 |
| Ibuibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-550 | 71610-0550-6071610-0550-8071610-0550-92 |
Other NDCs under ANDA 075682
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 |
|---|---|---|---|---|
| Ibuibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-275 |
| Ibuibuprofen | Ibuprofen 600 mg/1 | TabletOral | Proficient Rx LP | 63187-614 |
| Ibuibuprofen | Ibuprofen 400 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-682 |
| Ibuibuprofen | Ibuprofen 600 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-683 |
| Ibuibuprofen | Ibuprofen 800 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-684 |
| Ibuibuprofen | Ibuprofen 600 mg/1 | TabletOral | NuCare Pharmaceuticals Inc. | 66267-964 |
| Ibuibuprofen | Ibuprofen 800 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-963 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-967 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-968 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5854 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-969 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5855 |
| Ibuibuprofen | Ibuprofen 400 mg/1 | TabletOral | Proficient Rx LP | 71205-604 |
| Ibuibuprofen | Ibuprofen 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-501 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1468 |
| Ibuibuprofen | Ibuprofen 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-547 |
| Ibuibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-550 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5853 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9110 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9111 |
Showing 20 of 31.