Febuxostat
- Product NDC
- 63304-865
- 11-digit product format
- 633040865
- Labeler code
- 63304
- Product ID
- 63304-865_d618acad-1835-4148-a345-aa1054c367ff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Febuxostat
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ranbaxy Pharmaceuticals Inc.
- Application
- ANDA205392
- Marketing category
- ANDA
- Marketing start
- 2015-01-17
- Marketing end
- 0000-00-00
- Substance
- FEBUXOSTAT
- Active strength
- 80 mg/1
- Pharmacologic classes
- Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 63304-865-30 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 63304-865-69 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 63304-865-05 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 63304-865-30 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 63304-865-69 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 63304-865-05 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 63304-865-05 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 63304-865-69 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 63304-865-30 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63304-865-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9709-f424-e053-dadaa90a57ce | b5ccd05e-6866-4cf4-bfe7-ef2b8d76d873 |
| 63304-865-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9709-f424-e053-dadaa90a57ce | b5ccd05e-6866-4cf4-bfe7-ef2b8d76d873 |
| 63304-865-69 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9709-f424-e053-dadaa90a57ce | b5ccd05e-6866-4cf4-bfe7-ef2b8d76d873 |