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Olanzapine - Medication Information

Product NDC Code 70771-1416
Drug Name

Olanzapine

Type Generic
Pharm Class Atypical Antipsychotic [EPC]
Active Ingredients
Olanzapine 2.5 mg/1
Route ORAL
Dosage Form TABLET, FILM COATED
RxCUI drug identifier 200034,
283639,
312077,
312078,
312079,
314154
Application Number ANDA090459
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
70771-1416-0 1000 tablet, film coated in 1 bottle (70771-1416-0)
70771-1416-1 100 tablet, film coated in 1 bottle (70771-1416-1)
70771-1416-3 30 tablet, film coated in 1 bottle (70771-1416-3)
70771-1416-4 10 blister pack in 1 carton (70771-1416-4) / 10 tablet, film coated in 1 blister pack (70771-1416-2)
70771-1416-6 60 tablet, film coated in 1 bottle (70771-1416-6)
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Spl product data elements

Usually a list of ingredients in a drug product.
olanzapine olanzapine OLANZAPINE OLANZAPINE CROSPOVIDONE HYPROMELLOSES LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MAGNESIUM STEARATE TALC TITANIUM DIOXIDE XANTHAN GUM WHITE TO OFF-WHITE ROUND ZF28 olanzapine olanzapine OLANZAPINE OLANZAPINE CROSPOVIDONE HYPROMELLOSES LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MAGNESIUM STEARATE TALC TITANIUM DIOXIDE XANTHAN GUM WHITE TO OFF-WHITE ROUND ZF29 olanzapine olanzapine OLANZAPINE OLANZAPINE CROSPOVIDONE HYPROMELLOSES LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MAGNESIUM STEARATE TALC TITANIUM DIOXIDE XANTHAN GUM WHITE TO OFF-WHITE ROUND ZF30 olanzapine olanzapine OLANZAPINE OLANZAPINE HYPROMELLOSES LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MAGNESIUM STEARATE TALC TITANIUM DIOXIDE XANTHAN GUM CROSPOVIDONE WHITE TO OFF-WHITE ROUND ZF31 olanzapine olanzapine OLANZAPINE OLANZAPINE CROSPOVIDONE HYPROMELLOSES LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MAGNESIUM STEARATE TALC TITANIUM DIOXIDE XANTHAN GUM WHITE TO OFF-WHITE ELLIPTICAL-SHAPED ZF32 olanzapine olanzapine OLANZAPINE OLANZAPINE CROSPOVIDONE HYPROMELLOSES LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MAGNESIUM STEARATE TALC TITANIUM DIOXIDE XANTHAN GUM WHITE TO OFF-WHITE ELLIPTICAL-SHAPED ZF33

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1416-0 in bottle of 1,000 tablets Olanzapine Tablets USP, 2.5 mg Rx only 1,000 tablets NDC 70771-1417-0 in bottle of 1,000 tablets Olanzapine Tablets USP, 5 mg Rx only 1,000 tablets NDC 70771-1418-0 in bottle of 1,000 tablets Olanzapine Tablets USP, 7.5 mg Rx only 1,000 tablets NDC 70771-1419-0 in bottle of 1,000 tablets Olanzapine Tablets USP, 10 mg Rx only 1,000 tablets NDC 70771-1420-0 in bottle of 1,000 tablets Olanzapine Tablets USP, 15 mg Rx only 1,000 tablets NDC 70771-1421-0 in bottle of 1,000 tablets Olanzapine Tablets USP, 20 mg Rx only 1,000 tablets 2.5 mg label 5 mg label 7.5 mg label 10 mg label 15 mg label 20 mg label

Spl medguide

Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.
SPL MEDGUIDE

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API