FLUOXETINE
- Product NDC
- 31722-905
- 11-digit product format
- 317220905
- Labeler code
- 31722
- Product ID
- 31722-905_4ed2db42-7efb-4088-b709-b923901e349f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FLUOXETINE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA204597
- Marketing category
- ANDA
- Marketing start
- 2015-07-30
- 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
- 2018-12-31
- 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 |
|---|
| 31722-905-01 | FLUOXETINE | 100 in 1 BOTTLE | CAPSULE | 100 | | 5 |
| 31722-905-05 | FLUOXETINE | 500 in 1 BOTTLE | CAPSULE | 500 | | 5 |
| 31722-905-30 | FLUOXETINE | 30 in 1 BOTTLE | CAPSULE | 30 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUOXETINE HYDROCHLORIDE | ACTIVE INGREDIENT | I9W7N6B1KJ | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| FLUOXETINE | ACTIVE MOIETY | 01K63SUP8D | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-905 | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 3 package rows | 20170509_2a20b006-aad2-4cef-ac01-5acc557412c5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 31722-905-01 | 31722090501 | 100 in 1 BOTTLE | Historical |
| 31722-905-05 | 31722090505 | 500 in 1 BOTTLE | Historical |
| 31722-905-30 | 31722090530 | 30 in 1 BOTTLE | Historical |