Olanzapine
- Product NDC
- 33342-068
- 11-digit product format
- 333420068
- Labeler code
- 33342
- Product ID
- 33342-068_2b861570-6b18-4b2b-89aa-29ebde7770f5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA202862
- Marketing category
- ANDA
- Marketing start
- 2014-08-22
- Substance
- OLANZAPINE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Olanzapine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OLANZAPINE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7U69T4SZR |
| Rxcui | 200034, 283639, 312077, 312078, 312079, 314154 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33342-068-07 | Olanzapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 13 |
| 33342-068-11 | Olanzapine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 13 |
| 33342-068-12 | Olanzapine | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 13 |
| 33342-068-12 | Olanzapine | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 13 |
| 33342-068-44 | Olanzapine | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OLANZAPINE | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 4 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 4 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 4 | |
| OLANZAPINE | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-068 | OLANZAPINE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 12 | Current NDC, Legacy NDC, 5 package rows | 20250312_8e095987-bdea-42f2-9550-c7155cf07d30.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 |
|---|
| 33342-068-07 | 33342006807 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-068-07) | | 2014-08-22 | 0000-00-00 | No | No | Current |
| 33342-068-11 | 33342006811 | 100 TABLET, FILM COATED in 1 BOTTLE (33342-068-11) | | 2014-08-22 | 0000-00-00 | No | No | Current |
| 33342-068-12 | 33342006812 | 10 BLISTER PACK in 1 CARTON (33342-068-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2014-08-22 | 0000-00-00 | No | No | Current |
| 33342-068-44 | 33342006844 | 1000 TABLET, FILM COATED in 1 BOTTLE (33342-068-44) | | 2014-08-22 | 0000-00-00 | No | No | Current |