NDC 10135-657

Quetiapine Extended Release

Quetiapine

Quetiapine Extended Release is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is Quetiapine Fumarate.

• Product ID: 10135-657_6fd3392c-0934-402e-8b1a-75b2b9ca9d95
• NDC: 10135-657
• Product Type: Human Prescription Drug
• Proprietary Name: Quetiapine Extended Release
• Generic Name: Quetiapine
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2018-05-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209635
• Labeler Name: Marlex Pharmaceuticals Inc
• Substance Name: QUETIAPINE FUMARATE
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 10135-657-60

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10135-657-60)

• Marketing Start Date: 2018-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10135-657-60 [10135065760]

Quetiapine Extended Release TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA209635
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-05-01
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-20

Drug Details

Active Ingredients

Ingredient	Strength
QUETIAPINE FUMARATE	200 mg/1

OpenFDA Data

• SPL SET ID: a70d857a-50d3-4e69-828c-a72fd6b98c99
• Manufacturer:
  • Marlex Pharmaceuticals Inc
• UNII:
  • 2S3PL1B6UJ
• RxNorm Concept Unique ID - RxCUI:
  • 721796
  • 721794
  • 895670
  • 721791
• UPC Code:
  • 0310135657605
  • 0310135658602
  • 0310135659609
  • 0310135656608

Pharmacological Class

• Atypical Antipsychotic [EPC]

NDC Crossover Matching brand name "Quetiapine Extended Release" or generic name "Quetiapine"

NDC	Brand Name	Generic Name
70518-1744	Quetiapine Extended Release	Quetiapine Extended Release
70518-1823	Quetiapine Extended Release	Quetiapine Extended Release
71093-139	Quetiapine Extended Release	Quetiapine Extended Release
71093-136	Quetiapine Extended Release	Quetiapine Extended Release
71093-135	Quetiapine Extended Release	Quetiapine Extended Release
71093-138	Quetiapine Extended Release	Quetiapine Extended Release
71093-137	Quetiapine Extended Release	Quetiapine Extended Release
10135-657	Quetiapine Extended Release	Quetiapine Extended Release
10135-658	Quetiapine Extended Release	Quetiapine Extended Release
10135-659	Quetiapine Extended Release	Quetiapine Extended Release
10135-656	Quetiapine Extended Release	Quetiapine Extended Release
50228-382	Quetiapine Extended Release	Quetiapine Extended Release
50228-383	Quetiapine Extended Release	Quetiapine Extended Release
50228-380	Quetiapine Extended Release	Quetiapine Extended Release
50228-384	Quetiapine Extended Release	Quetiapine Extended Release
50228-381	Quetiapine Extended Release	Quetiapine Extended Release
0093-2063	Quetiapine	Quetiapine
0093-8162	Quetiapine	Quetiapine
0093-8163	Quetiapine	Quetiapine
0093-8164	Quetiapine	Quetiapine
0093-8165	Quetiapine	Quetiapine
0093-8166	Quetiapine	Quetiapine
0310-0271	SEROQUEL	quetiapine