Fluoxetine
- Product NDC
- 63304-632
- 11-digit product format
- 633040632
- Labeler code
- 63304
- Product ID
- 63304-632_db910c53-3c87-40cb-b799-53bbb95a983c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA076990
- Marketing category
- ANDA
- Marketing start
- 2018-08-16
- Marketing end
- 0000-00-00
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ce7d40ce-bfb8-ee15-a060-423ec90d7ac9 | Product name | 6 | 20250331 |
| e5b459e3-ddce-4802-aab4-2c901d71ae85 | Product name | 5 | 20250129 |
| 6d3d5b3a-d6b8-8417-8428-6414b08f1464 | Product name | 3 | 20240130 |
| e7177a8f-11de-ee90-ca22-068e6ef54cf5 | Product name | 4 | 20230104 |
| 82da1192-6e97-fa73-2f85-6a50c10b4704 | Product name | 3 | 20161212 |
| 877783eb-030c-6e3f-0979-804cf94d8856 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63304-632-01 | EA - Each | 63304-632 | a1e16226-7529-4a99-adc3-5046073a457e | 1 | 2012-07-24 |
| 63304-632-30 | EA - Each | 63304-632 | 81a3b2a1-f519-4b6d-9b8f-1cd2d9674aba | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313989 | FLUoxetine 40 MG Oral Capsule | PSN | 62e08a06-2f62-42aa-828f-5c2d1415657e | 4 |
| 313989 | fluoxetine 40 MG Oral Capsule | SCD | 62e08a06-2f62-42aa-828f-5c2d1415657e | 4 |
| 313989 | fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule | SY | 62e08a06-2f62-42aa-828f-5c2d1415657e | 4 |
| 313989 | FLUoxetine 40 MG Oral Capsule | PSN | eb231077-fa47-4469-b3c5-4e13d2365252 | 3 |
| 313989 | fluoxetine 40 MG Oral Capsule | SCD | eb231077-fa47-4469-b3c5-4e13d2365252 | 3 |
| 313989 | fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule | SY | eb231077-fa47-4469-b3c5-4e13d2365252 | 3 |
| 313989 | FLUoxetine 40 MG Oral Capsule | PSN | 6b8ebc39-da88-4491-bbf0-9be758c2ddfc | 2 |
| 313989 | fluoxetine 40 MG Oral Capsule | SCD | 6b8ebc39-da88-4491-bbf0-9be758c2ddfc | 2 |
| 313989 | fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule | SY | 6b8ebc39-da88-4491-bbf0-9be758c2ddfc | 2 |
| 313989 | FLUoxetine 40 MG Oral Capsule | PSN | e6c2595a-1470-4cf4-93ea-0fedf917cf85 | 1 |
| 313989 | fluoxetine 40 MG Oral Capsule | SCD | e6c2595a-1470-4cf4-93ea-0fedf917cf85 | 1 |
| 313989 | fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule | SY | e6c2595a-1470-4cf4-93ea-0fedf917cf85 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63304-632-01 | 63304063201 | 100 CAPSULE in 1 BOTTLE (63304-632-01) | 100 capsule | 2018-08-16 | 0000-00-00 | No | No | Current |
| 63304-632-05 | 63304063205 | 500 CAPSULE in 1 BOTTLE (63304-632-05) | 500 capsule | 2018-08-16 | 0000-00-00 | No | No | Current |
| 63304-632-10 | 63304063210 | 1000 CAPSULE in 1 BOTTLE (63304-632-10) | 1000 capsule | 2018-08-16 | 0000-00-00 | No | No | Current |
| 63304-632-30 | 63304063230 | 30 CAPSULE in 1 BOTTLE (63304-632-30) | 30 capsule | 2018-08-16 | 0000-00-00 | No | No | Current |
| 63304-632-80 | 63304063280 | 100 BLISTER PACK in 1 CARTON (63304-632-80) > 1 CAPSULE in 1 BLISTER PACK | 100 blister pack | 2018-08-16 | 0000-00-00 | No | No | Current |
| 63304-632-90 | 63304063290 | 90 CAPSULE in 1 BOTTLE (63304-632-90) | 90 capsule | 2018-08-16 | 0000-00-00 | No | No | Current |