Fluoxetine
- Product NDC
- 54838-523
- 11-digit product format
- 548380523
- Labeler code
- 54838
- Product ID
- 54838-523_bda5665d-4bcd-4426-9397-e438485d0d29
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA077849
- Marketing category
- ANDA
- Marketing start
- 2009-08-27
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 20 mg/5mL
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluoxetine
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FLUOXETINE HYDROCHLORIDE | 20 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | I9W7N6B1KJ |
| Rxcui | 310386 |
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 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 82da1192-6e97-fa73-2f85-6a50c10b4704 | Product name | 3 | 20161212 |
| 877783eb-030c-6e3f-0979-804cf94d8856 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54838-523-40 | Fluoxetine | 120 mL in 1 BOTTLE, PLASTIC | LIQUID | 120 | 39 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54838-523-40 | ML - Milliliter | 54838-523 | 58d228df-e29c-4c63-a041-a39e514120c2 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Fluoxetine Hydrochloride | ACTIVE INGREDIENT | I9W7N6B1KJ | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] | 17 | |
| Fluoxetine | ACTIVE MOIETY | 01K63SUP8D | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] | 17 | |
| alcohol | INACTIVE INGREDIENT | 3K9958V90M | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] | 17 | |
| benzoic acid | INACTIVE INGREDIENT | 8SKN0B0MIM | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] | 17 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] | 17 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] | 17 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) LIQUID [SILARX PHARMACEUTICALS, INC] | 17 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310386 | FLUoxetine 20 MG in 5 mL Oral Solution | PSN | c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1 | 39 |
| 310386 | fluoxetine 4 MG/ML Oral Solution | SCD | c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1 | 39 |
| 310386 | fluoxetine 20 MG per 5 ML Oral Solution | SY | c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1 | 39 |
| 310386 | fluoxetine 4 MG/ML (as fluoxetine HCl) Oral Solution | SY | c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1 | 39 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 54838-523-40 | 54838052340 | 120 mL in 1 BOTTLE, PLASTIC (54838-523-40) | 120 ml | 2009-08-27 | 0000-00-00 | No | No | Current |