Olanzapine and Fluoxetine
- Product NDC
- 49884-252
- 11-digit product format
- 498840252
- Labeler code
- 49884
- Product ID
- 49884-252_d4b26d87-0345-449f-88c1-2d6a9eefd699
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- olanzapine and fuoxetine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Par Health USA, LLC
- Application
- ANDA077742
- Marketing category
- ANDA
- Marketing start
- 2012-11-26
- Substance
- FLUOXETINE HYDROCHLORIDE; OLANZAPINE
- Active strength
- 25; 12 mg/1; mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Olanzapine and Fluoxetine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOXETINE HYDROCHLORIDE | 25 mg/1 |
| OLANZAPINE | 12 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7U69T4SZR, I9W7N6B1KJ |
| Rxcui | 403969, 403970, 403971, 403972, 721787 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49884-252-11 | Olanzapine and Fluoxetine | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUOXETINE HYDROCHLORIDE | ACTIVE INGREDIENT | I9W7N6B1KJ | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| OLANZAPINE | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| FLUOXETINE | ACTIVE MOIETY | 01K63SUP8D | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| METHYL ALCOHOL | INACTIVE INGREDIENT | Y4S76JWI15 | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-252 | OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [ENDO USA, INC.] | 15 | Current NDC, Legacy NDC, 1 package rows | 20241215_2f6ceda3-3edc-4427-98a6-23e3c930c44d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49884-252-11 | 49884025211 | 30 CAPSULE in 1 BOTTLE, PLASTIC (49884-252-11) | 30 capsule | 2012-11-26 | 0000-00-00 | No | No | Current |