Fluoxetine Hydrochloride
- Product NDC
- 0781-2823
- 11-digit product format
- 007812823
- Labeler code
- 0781
- Product ID
- 0781-2823_1c89f15b-eefd-4be2-9055-1374a76669cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA075049
- Marketing category
- ANDA
- Marketing start
- 2001-08-02
- Marketing end
- 2022-10-31
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
|---|---|---|---|---|---|
| 0781-2823-01 | EA - Each | 0781-2823 | be56d525-5805-4fac-bacc-46663a044a7c | 1 | 2012-07-24 |
| 0781-2823-10 | EA - Each | 0781-2823 | 4f3341a2-1eb1-474a-968c-a9a926da24db | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310384 | FLUoxetine 10 MG Oral Capsule | PSN | 79dc6790-d679-4e6e-9e3f-7de8e88d4837 | 2 |
| 310384 | fluoxetine 10 MG Oral Capsule | SCD | 79dc6790-d679-4e6e-9e3f-7de8e88d4837 | 2 |
| 310384 | fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule | SY | 79dc6790-d679-4e6e-9e3f-7de8e88d4837 | 2 |
| 310384 | FLUoxetine 10 MG Oral Capsule | PSN | f7994951-93d4-42cb-88f5-b8ad8e9f5037 | 1 |
| 310384 | fluoxetine 10 MG Oral Capsule | SCD | f7994951-93d4-42cb-88f5-b8ad8e9f5037 | 1 |
| 310384 | fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule | SY | f7994951-93d4-42cb-88f5-b8ad8e9f5037 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0781-2823-01 | 00781282301 | 100 CAPSULE in 1 BOTTLE (0781-2823-01) | 100 capsule | 2001-08-02 | 2022-08-31 | No | No | Current |
| 0781-2823-10 | 00781282310 | 1000 CAPSULE in 1 BOTTLE (0781-2823-10) | 1000 capsule | 2001-08-02 | 2022-09-30 | No | No | Current |