Fluoxetine
- Product NDC
- 50090-2776
- 11-digit product format
- 500902776
- Labeler code
- 50090
- Product ID
- 50090-2776_e60e12e1-30b0-4a67-8832-e34627f6f77f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA076001
- Marketing category
- ANDA
- Marketing start
- 2002-01-29
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-2776-0 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-baf7-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-2776-0 | Fluoxetine | 32 in 1 BOX, UNIT-DOSE | CAPSULE | 32 | 15 | |
| 50090-2776-0 | Fluoxetine | 1 in 1 BLISTER PACK | CAPSULE | 1 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-2776-0 | EA - Each | 50090-2776 | b5ffca77-008a-4229-88c3-dbfed03c8d76 | 1 | 2019-04-11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-2776 | FLUOXETINE CAPSULE [A-S MEDICATION SOLUTIONS] | 15 | Legacy NDC, 2 package rows | 20210818_c1dd46d3-0d09-4f62-81ca-be32409b24c9.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310384 | FLUoxetine 10 MG Oral Capsule | PSN | c1dd46d3-0d09-4f62-81ca-be32409b24c9 | 15 |
| 310385 | FLUoxetine 20 MG Oral Capsule | PSN | c1dd46d3-0d09-4f62-81ca-be32409b24c9 | 15 |
| 310384 | fluoxetine 10 MG Oral Capsule | SCD | c1dd46d3-0d09-4f62-81ca-be32409b24c9 | 15 |
| 310385 | fluoxetine 20 MG Oral Capsule | SCD | c1dd46d3-0d09-4f62-81ca-be32409b24c9 | 15 |
| 310384 | fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule | SY | c1dd46d3-0d09-4f62-81ca-be32409b24c9 | 15 |
| 310385 | fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule | SY | c1dd46d3-0d09-4f62-81ca-be32409b24c9 | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-2776-0 | 50090277600 | 32 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-2776-0) > 1 CAPSULE in 1 BLISTER PACK | 32 blister pack | 2017-01-12 | 0000-00-00 | No | No | Current |