NDC 52343-043

OLANZAPINE

Olanzapine

OLANZAPINE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Acetris Health, Llc. The primary component is Olanzapine.

• Product ID: 52343-043_4354fe74-d83c-4a15-b3de-2b04c8950eeb
• NDC: 52343-043
• Product Type: Human Prescription Drug
• Proprietary Name: OLANZAPINE
• Generic Name: Olanzapine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2014-09-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202050
• Labeler Name: ACETRIS HEALTH, LLC
• Substance Name: OLANZAPINE
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 52343-043-30

30 TABLET in 1 BOTTLE (52343-043-30)

• Marketing Start Date: 2014-09-26
• Marketing End Date: 2021-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52343-043-99 [52343004399]

OLANZAPINE TABLET

• Marketing Category: ANDA
• Application Number: ANDA202050
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-26
• Marketing End Date: 2021-05-01

NDC 52343-043-30 [52343004330]

OLANZAPINE TABLET

• Marketing Category: ANDA
• Application Number: ANDA202050
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-26
• Marketing End Date: 2021-05-01

Drug Details

Active Ingredients

Ingredient	Strength
OLANZAPINE	20 mg/1

OpenFDA Data

• SPL SET ID: 13591d0b-0d4a-4bb4-bf49-d54ba5ca1759
• Manufacturer:
  • ACETRIS HEALTH, LLC
• UNII:
  • N7U69T4SZR
• RxNorm Concept Unique ID - RxCUI:
  • 200034
  • 312077
  • 312079
  • 312078
  • 314154
  • 283639
• UPC Code:
  • 0352343040305
  • 0352343042309
  • 0352343039309
  • 0352343038302

Pharmacological Class

• 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