NDC 0615-7987

Quetiapine

Quetiapine

Quetiapine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Quetiapine Fumarate.

• Product ID: 0615-7987_087b49e9-6968-4472-8a97-fa2d71f8a001
• NDC: 0615-7987
• Product Type: Human Prescription Drug
• Proprietary Name: Quetiapine
• Generic Name: Quetiapine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-03-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202152
• Labeler Name: NCS HealthCare of KY, Inc dba Vangard Labs
• Substance Name: QUETIAPINE FUMARATE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0615-7987-05

15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7987-05)

• Marketing Start Date: 2016-05-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0615-7987-05 [00615798705]

Quetiapine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA202152
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-05-06

NDC 0615-7987-39 [00615798739]

Quetiapine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA202152
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-05-06

NDC 0615-7987-30 [00615798730]

Quetiapine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA202152
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-05-13

Drug Details

Active Ingredients

Ingredient	Strength
QUETIAPINE FUMARATE	50 mg/1

OpenFDA Data

• SPL SET ID: bb5a14a3-0283-4eb2-88e4-8e53375394a2
• Manufacturer:
  • NCS HealthCare of KY, Inc dba Vangard Labs
• UNII:
  • 2S3PL1B6UJ
• RxNorm Concept Unique ID - RxCUI:
  • 312743
  • 616487
  • 312744

Pharmacological Class

• Atypical Antipsychotic [EPC]

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

NDC	Brand Name	Generic Name
0093-2063	Quetiapine	Quetiapine
0093-8162	Quetiapine	Quetiapine
0093-8163	Quetiapine	Quetiapine
0093-8164	Quetiapine	Quetiapine
0093-8165	Quetiapine	Quetiapine
0093-8166	Quetiapine	Quetiapine
68071-2038	Quetiapine	Quetiapine
68071-4161	Quetiapine	Quetiapine
68788-7185	Quetiapine	Quetiapine
68788-7184	Quetiapine	Quetiapine
68788-7186	Quetiapine	Quetiapine
68788-7412	Quetiapine	Quetiapine
70518-0229	Quetiapine	Quetiapine
70518-0239	Quetiapine	Quetiapine
70518-0289	Quetiapine	Quetiapine
70518-0345	Quetiapine	Quetiapine
70518-0432	Quetiapine	Quetiapine
70518-0889	Quetiapine	Quetiapine
70518-0808	Quetiapine	Quetiapine
70518-0825	Quetiapine	Quetiapine
70518-0570	Quetiapine	Quetiapine
70518-0752	Quetiapine	Quetiapine
70518-1477	Quetiapine	Quetiapine
70518-1569	Quetiapine	Quetiapine
71205-026	Quetiapine	Quetiapine
71335-0432	Quetiapine	Quetiapine
0615-7987	Quetiapine	Quetiapine
0615-7988	Quetiapine	Quetiapine
0615-7986	Quetiapine	Quetiapine
0615-8119	Quetiapine	Quetiapine
16714-452	Quetiapine	Quetiapine
16729-145	Quetiapine	Quetiapine
16714-455	Quetiapine	Quetiapine
16729-147	Quetiapine	Quetiapine
16714-456	Quetiapine	Quetiapine
16714-453	Quetiapine	Quetiapine
16714-457	Quetiapine	Quetiapine
16729-146	Quetiapine	Quetiapine
16729-149	Quetiapine	Quetiapine
16714-454	Quetiapine	Quetiapine
16729-150	Quetiapine	Quetiapine
16729-148	Quetiapine	Quetiapine
33342-135	QUETIAPINE	QUETIAPINE
33342-137	QUETIAPINE	QUETIAPINE
33342-134	QUETIAPINE	QUETIAPINE
33342-136	QUETIAPINE	QUETIAPINE
50090-2831	Quetiapine	Quetiapine
50090-2307	Quetiapine	Quetiapine
50090-2690	Quetiapine	Quetiapine
50090-2830	Quetiapine	Quetiapine