Prescription drug · ANDA
Ibu (Ibuprofen) NDC 71205-604
Ibuprofen 400 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-604-15 | 7120506041571205060415 | 15 TABLET in 1 BOTTLE (71205-604-15)Marketed from Sep 27, 2021 | |
| 71205-604-20 | 7120506042071205060420 | 20 TABLET in 1 BOTTLE (71205-604-20)Marketed from Sep 27, 2021 | |
| 71205-604-21 | 7120506042171205060421 | 21 TABLET in 1 BOTTLE (71205-604-21)Marketed from Sep 27, 2021 | |
| 71205-604-30 | 7120506043071205060430 | 30 TABLET in 1 BOTTLE (71205-604-30)Marketed from Aug 27, 2021 | |
| 71205-604-40 | 7120506044071205060440 | 40 TABLET in 1 BOTTLE (71205-604-40)Marketed from Sep 27, 2021 | |
| 71205-604-60 | 7120506046071205060460 | 60 TABLET in 1 BOTTLE (71205-604-60)Marketed from Aug 27, 2021 | |
| 71205-604-90 | 7120506049071205060490 | 90 TABLET in 1 BOTTLE (71205-604-90)Marketed from Aug 27, 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)
- Ibu
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 400 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- 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 71205-604_f49b4e82-120c-4012-b4b3-78c0f89ae8fdSPL ID f49b4e82-120c-4012-b4b3-78c0f89ae8fdSPL set ID ea6f626d-cda3-46e2-9ac9-4e72204cb726UNII WK2XYI10QMUPC 0371205604158
- 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
N471205060415followed by a unit qualifier and the quantityPackage 71205-0604-15. 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 71205-604
- What is NDC 71205-604?
- 71205-604 is the product NDC for Ibu (ibuprofen), Ibuprofen 400 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 7 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?
- Proficient Rx LP, NDC labeler code 71205. 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 800 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3053 | 68071-3053-0068071-3053-0168071-3053-02+2 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 |
| Ibuibuprofen | Ibuprofen 800 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3053 |
| 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 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 |
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