Prescription drug · ANDA
Ibuprofen NDC 76420-577
Ibuprofen 800 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-577-01 | 76420057701 | 100 TABLET in 1 BOTTLE (76420-577-01)Marketed from Jul 20, 2023 | |
| 76420-577-30 | 76420057730 | 30 TABLET in 1 BOTTLE (76420-577-30)Marketed from Jul 20, 2023 | |
| 76420-577-60 | 76420057760 | 60 TABLET in 1 BOTTLE (76420-577-60)Marketed from Jul 20, 2023 | |
| 76420-577-90 | 76420057790 | 90 TABLET in 1 BOTTLE (76420-577-90)Marketed from Jul 20, 2023 |
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
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213794
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 76420-577_0706e837-6b65-31c5-e063-6294a90a85e5SPL ID 0706e837-6b65-31c5-e063-6294a90a85e5SPL set ID 793e4b36-8208-4fa3-9f4f-9e9e72648280RxCUI 197805, 197806, 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
N476420057701followed by a unit qualifier and the quantityPackage 76420-0577-01. 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.
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 | NorthStar Rx LLC | 72603-909 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | NorthStar Rx LLC | 72603-910 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2998 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-361 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-360 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-362 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-045 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | A-S Medication Solutions | 50090-5435 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | A-S Medication Solutions | 50090-5433 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-5445 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-5444 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2682 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-5446 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3861 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2683 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2689 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3696 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4010 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-897 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4341 |
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