letrozole
- Product NDC
- 68382-363
- 11-digit product format
- 683820363
- Labeler code
- 68382
- Product ID
- 68382-363_a7dfded8-37bd-4d82-afff-2065e6ba24a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- letrozole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA090405
- Marketing category
- ANDA
- Marketing start
- 2011-06-03
- Marketing end
- 0000-00-00
- Substance
- LETROZOLE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 68382-363-10 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 68382-363-30 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 68382-363-06 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 68382-363-10 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 68382-363-30 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 68382-363-06 | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 68382-363-10 | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 68382-363-30 | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 68382-363-06 | 110d247fa046… | a55b01930146… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68382-363-06 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d9a0-8e05-e053-dbdaa90a074a | 17b4ceca-b0f9-4e44-95f8-e33554962b05 |
| 68382-363-10 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d9a0-8e05-e053-dbdaa90a074a | 17b4ceca-b0f9-4e44-95f8-e33554962b05 |
| 68382-363-30 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d9a0-8e05-e053-dbdaa90a074a | 17b4ceca-b0f9-4e44-95f8-e33554962b05 |