FLUOXETINE
- Product NDC
- 31722-904
- 11-digit product format
- 317220904
- Labeler code
- 31722
- Product ID
- 31722-904_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
- 20 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#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 31722-904-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-da95-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 |
| 31722-904-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-da95-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 |
| 31722-904-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-da95-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 |
| 31722-904-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-da95-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 table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-904-01 | FLUOXETINE | 100 in 1 BOTTLE | CAPSULE | 100 | | 5 |
| 31722-904-05 | FLUOXETINE | 500 in 1 BOTTLE | CAPSULE | 500 | | 5 |
| 31722-904-10 | FLUOXETINE | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 5 |
| 31722-904-30 | 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 |
|---|
| 31722-904 | FLUOXETINE CAPSULE [CAMBER PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 4 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 |
|---|
| 31722-904-01 | 31722090401 | 100 in 1 BOTTLE | Historical |
| 31722-904-05 | 31722090405 | 500 in 1 BOTTLE | Historical |
| 31722-904-10 | 31722090410 | 1000 in 1 BOTTLE | Historical |
| 31722-904-30 | 31722090430 | 30 in 1 BOTTLE | Historical |