Prescription drug · ANDA
Ibuprofen NDC 63629-1470
Ibuprofen 800 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-1470-0 | 6362914700063629147000 | 84 TABLET in 1 BOTTLE (63629-1470-0)Marketed from Mar 2, 2010 | |
| 63629-1470-1 | 6362914700163629147001 | 20 TABLET in 1 BOTTLE (63629-1470-1)Marketed from Dec 21, 2021 | |
| 63629-1470-2 | 6362914700263629147002 | 42 TABLET in 1 BOTTLE (63629-1470-2)Marketed from May 8, 2018 | |
| 63629-1470-3 | 6362914700363629147003 | 40 TABLET in 1 BOTTLE (63629-1470-3)Marketed from Dec 21, 2021 | |
| 63629-1470-4 | 6362914700463629147004 | 21 TABLET in 1 BOTTLE (63629-1470-4)Marketed from Dec 21, 2021 | |
| 63629-1470-5 | 6362914700563629147005 | 30 TABLET in 1 BOTTLE (63629-1470-5)Marketed from Dec 21, 2021 | |
| 63629-1470-6 | 6362914700663629147006 | 90 TABLET in 1 BOTTLE (63629-1470-6)Marketed from Dec 21, 2021 | |
| 63629-1470-7 | 6362914700763629147007 | 100 TABLET in 1 BOTTLE (63629-1470-7)Marketed from Dec 21, 2021 | |
| 63629-1470-8 | 6362914700863629147008 | 120 TABLET in 1 BOTTLE (63629-1470-8)Marketed from Dec 21, 2021 | |
| 63629-1470-9 | 6362914700963629147009 | 60 TABLET in 1 BOTTLE (63629-1470-9)Marketed from Dec 21, 2021 |
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 — 800 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078558
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 63629-1470_fa931f19-3b64-492e-9bd6-0be85e037dc9SPL ID fa931f19-3b64-492e-9bd6-0be85e037dc9SPL set ID e90c573d-eb0f-45a5-94d1-efdd3d2b7a11RxCUI 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
N463629147000followed by a unit qualifier and the quantityPackage 63629-1470-00. 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 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 63629-1470
- What is NDC 63629-1470?
- 63629-1470 is the product NDC for Ibuprofen, Ibuprofen 800 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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?
- 674 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 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 800 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-725 | 82461-0725-90 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Medcore LLC | 82461-724 | 82461-0724-90 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Aurohealth LLC | 58602-913 | 58602-0913-1758602-0913-40 |
| Ibuprofen | Ibuprofen 600 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-738 | 67877-0738-0167877-0738-0567877-0738-30+3 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 800 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-739 | 67877-0739-0167877-0739-0567877-0739-30+4 more |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | GOODSENSE | 50804-185 | 50804-0185-0150804-0185-02 |
Other NDCs under ANDA 078558
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 800 mg/1 | TabletOral | A-S Medication Solutions | 50090-6616 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-464 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-465 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-466 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2583 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | American Health Packaging | 60687-446 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | American Health Packaging | 60687-457 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | American Health Packaging | 60687-468 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Proficient Rx LP | 63187-022 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Proficient Rx LP | 63187-489 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Proficient Rx LP | 63187-527 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Proficient Rx LP | 63187-962 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-464 |
| Ibuprofen | Ibuprofen 600 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-465 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-466 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3415 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-898 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0047 |
| Ibuprofen | Ibuprofen 400 mg/1 | TabletOral | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 83209-464 |
| Ibuprofen | Ibuprofen 800 mg/1 | TabletOral | PHOENIX RX LLC | 85509-1466 |