NDC 0378-5510

Olanzapine

Olanzapine

Olanzapine is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Olanzapine.

• Product ID: 0378-5510_25f5f7f8-2b73-476a-821d-4f020c395b5f
• NDC: 0378-5510
• Product Type: Human Prescription Drug
• Proprietary Name: Olanzapine
• Generic Name: Olanzapine
• Dosage Form: Tablet, Orally Disintegrating
• Route of Administration: ORAL
• Marketing Start Date: 2014-05-12
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202285
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: OLANZAPINE
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0378-5510-93

30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-5510-93)

• Marketing Start Date: 2014-05-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-5510-93 [00378551093]

Olanzapine TABLET, ORALLY DISINTEGRATING

• Marketing Category: ANDA
• Application Number: ANDA202285
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-05-12

NDC 0378-5510-77 [00378551077]

Olanzapine TABLET, ORALLY DISINTEGRATING

• Marketing Category: ANDA
• Application Number: ANDA202285
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-05-12
• Marketing End Date: 2015-07-06

NDC 0378-5510-05 [00378551005]

Olanzapine TABLET, ORALLY DISINTEGRATING

• Marketing Category: ANDA
• Application Number: ANDA202285
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-05-12
• Marketing End Date: 2015-07-06

Drug Details

Active Ingredients

Ingredient	Strength
OLANZAPINE	5 mg/1

OpenFDA Data

• SPL SET ID: 35b52ceb-5c07-49c5-9b1d-4708db66eaff
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • N7U69T4SZR
• RxNorm Concept Unique ID - RxCUI:
  • 351108
  • 351107
  • 314155
  • 312076
• UPC Code:
  • 0303785513933
  • 0303785511939
  • 0303785510932

Pharmacological Class

• Atypical Antipsychotic [EPC]
• Atypical Antipsychotic [EPC]

NDC Crossover Matching brand name "Olanzapine" or generic name "Olanzapine"

NDC	Brand Name	Generic Name
67877-175	Olanzapine	Olanzapine
67877-174	Olanzapine	Olanzapine
67877-172	Olanzapine	Olanzapine
67877-173	Olanzapine	Olanzapine
67877-176	Olanzapine	Olanzapine
67877-177	Olanzapine	Olanzapine
68084-529	Olanzapine	Olanzapine
68084-723	Olanzapine	Olanzapine
68084-528	Olanzapine	Olanzapine
68084-740	Olanzapine	Olanzapine
68084-525	Olanzapine	Olanzapine
68258-7095	Olanzapine	Olanzapine
68258-7152	Olanzapine	Olanzapine
68258-7153	Olanzapine	Olanzapine
68258-7154	Olanzapine	Olanzapine
68382-365	olanzapine	olanzapine
68382-368	olanzapine	olanzapine
68258-7096	Olanzapine	Olanzapine
68382-367	olanzapine	olanzapine
68382-364	olanzapine	olanzapine
68382-366	olanzapine	olanzapine
68382-369	olanzapine	olanzapine
68788-7161	Olanzapine	Olanzapine
0517-0955	Olanzapine	Olanzapine
69189-5510	Olanzapine	Olanzapine
69543-384	Olanzapine	Olanzapine
69543-380	Olanzapine	Olanzapine
69543-381	Olanzapine	Olanzapine
69543-383	Olanzapine	Olanzapine
69543-382	Olanzapine	Olanzapine
69543-385	Olanzapine	Olanzapine
69807-2012	Olanzapine	Olanzapine
69807-2011	Olanzapine	Olanzapine
69807-2013	Olanzapine	Olanzapine
70518-0026	Olanzapine	Olanzapine
70518-0148	Olanzapine	Olanzapine
70518-0145	Olanzapine	Olanzapine
70518-0149	Olanzapine	Olanzapine
70518-0314	Olanzapine	Olanzapine
70518-0477	Olanzapine	Olanzapine
70518-0110	Olanzapine	Olanzapine
70518-0616	Olanzapine	Olanzapine
70518-0144	Olanzapine	Olanzapine
70518-0433	Olanzapine	Olanzapine
70518-1206	Olanzapine	Olanzapine
70518-0921	Olanzapine	Olanzapine
70518-1207	Olanzapine	Olanzapine
70518-0615	Olanzapine	Olanzapine
70518-1115	Olanzapine	Olanzapine
70518-1154	Olanzapine	Olanzapine