Fluoxetine
- Product NDC
- 10544-583
- 11-digit product format
- 105440583
- Labeler code
- 10544
- Product ID
- 10544-583_11813bd5-169f-0fa5-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA078619
- Marketing category
- ANDA
- Marketing start
- 2012-01-18
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-583-90 | Fluoxetine | 90 in 1 BOTTLE | CAPSULE | 90 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUOXETINE HYDROCHLORIDE | ACTIVE INGREDIENT | I9W7N6B1KJ | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| FLUOXETINE | ACTIVE MOIETY | 01K63SUP8D | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-583 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | Legacy NDC, 1 package rows | 20150317_24b0e72d-2dd3-4355-8ba4-6101b127a36b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-583-90 | 10544058390 | 90 in 1 BOTTLE | Historical |