Olanzapine
- Product NDC
- 0904-6283
- 11-digit product format
- 009046283
- Labeler code
- 0904
- Product ID
- 0904-6283_4a0e8cdb-f3fa-4d97-8aac-f30a3f9c1545
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA076255
- Marketing category
- ANDA
- Marketing start
- 2012-04-23
- Marketing end
- 0000-00-00
- Substance
- OLANZAPINE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OLANZAPINE | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 3 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 3 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6283 | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 9 | Legacy NDC | 20241010_296e29ff-206d-409a-8c0f-10b2ec081be5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-6283-61 | 00904628361 | 100 BLISTER PACK in 1 CARTON (0904-6283-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2012-04-23 | 0000-00-00 | No | No | Current |