Prescription drug · ANDA
Ibuprofen NDC 80425-0424
Ibuprofen 600 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0424-1 | 80425042401 | 30 TABLET in 1 BOTTLE (80425-0424-1)Marketed from Aug 1, 2024 | |
| 80425-0424-2 | 80425042402 | 60 TABLET in 1 BOTTLE (80425-0424-2)Marketed from Aug 1, 2024 | |
| 80425-0424-3 | 80425042403 | 90 TABLET in 1 BOTTLE (80425-0424-3)Marketed from Aug 1, 2024 | |
| 80425-0424-4 | 80425042404 | 100 TABLET in 1 BOTTLE (80425-0424-4)Marketed from Aug 1, 2024 |
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)
- Ibuprofen
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- 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 80425-0424_276e7c94-9e24-5c17-e063-6394a90a32f0SPL ID 276e7c94-9e24-5c17-e063-6394a90a32f0SPL set ID 1ef5693b-d00a-28fb-e063-6294a90a7edeRxCUI 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
N480425042401followed by a unit qualifier and the quantityPackage 80425-0424-01. 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
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. 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 80425-0424
- What is NDC 80425-0424?
- 80425-0424 is the product NDC for Ibuprofen, Ibuprofen 600 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 4 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?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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?
- 664 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 200 mg/1 | TabletOral | Aurohealth LLC | 58602-913 | 58602-0913-1758602-0913-40 |
| Ibuprofen | Ibuprofen 800 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-739 | 67877-0739-0167877-0739-0567877-0739-30+4 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 600 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-738 | 67877-0738-0167877-0738-0567877-0738-30+3 more |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | GOODSENSE | 50804-185 | 50804-0185-0150804-0185-02 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Shield Pharmaceuticals Corp | 83059-0180 | 83059-0180-04 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Gobrands, Inc. (Goodnow) | 82501-1010 | 82501-1010-00 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4741 | 70518-4741-0070518-4741-02 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | P & L Development, LLC | 59726-003 | 59726-0003-50 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-143 | 72288-0143-7872288-0143-90 |
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. | 68071-2947 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | A-S Medication Solutions | 50090-6676 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | A-S Medication Solutions | 50090-6677 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2998 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Sportpharm LLC | 85766-218 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Sportpharm LLC | 85766-219 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Sportpharm LLC | 85766-220 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-360 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3861 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-361 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-362 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2682 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2683 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2689 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | A-S Medication Solutions | 50090-5433 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | A-S Medication Solutions | 50090-5435 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-5445 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-5444 |
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