NDC 67046-637

Quetiapine fumarate

Quetiapine

Quetiapine fumarate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Contract Pharmacy Services-pa. The primary component is Quetiapine Fumarate.

• Product ID: 67046-637_5a19e429-21d1-efd1-e053-2a91aa0acb63
• NDC: 67046-637
• Product Type: Human Prescription Drug
• Proprietary Name: Quetiapine fumarate
• Generic Name: Quetiapine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-09-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201109
• Labeler Name: Contract Pharmacy Services-PA
• Substance Name: QUETIAPINE FUMARATE
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 67046-637-07

7 TABLET in 1 BLISTER PACK (67046-637-07)

• Marketing Start Date: 2017-09-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67046-637-07 [67046063707]

Quetiapine fumarate TABLET

• Marketing Category: ANDA
• Application Number: ANDA201109
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-09-26

NDC 67046-637-15 [67046063715]

Quetiapine fumarate TABLET

• Marketing Category: ANDA
• Application Number: ANDA201109
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-09-26

NDC 67046-637-21 [67046063721]

Quetiapine fumarate TABLET

• Marketing Category: ANDA
• Application Number: ANDA201109
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-09-26

NDC 67046-637-30 [67046063730]

Quetiapine fumarate TABLET

• Marketing Category: ANDA
• Application Number: ANDA201109
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-09-26

NDC 67046-637-20 [67046063720]

Quetiapine fumarate TABLET

• Marketing Category: ANDA
• Application Number: ANDA201109
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-09-26

NDC 67046-637-14 [67046063714]

Quetiapine fumarate TABLET

• Marketing Category: ANDA
• Application Number: ANDA201109
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-09-26

NDC 67046-637-60 [67046063760]

Quetiapine fumarate TABLET

• Marketing Category: ANDA
• Application Number: ANDA201109
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-09-26

NDC 67046-637-28 [67046063728]

Quetiapine fumarate TABLET

• Marketing Category: ANDA
• Application Number: ANDA201109
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-09-26

Drug Details

Active Ingredients

Ingredient	Strength
QUETIAPINE FUMARATE	200 mg/1

OpenFDA Data

• SPL SET ID: 5a19e429-21d0-efd1-e053-2a91aa0acb63
• Manufacturer:
  • Contract Pharmacy Services-PA
• UNII:
  • 2S3PL1B6UJ
• RxNorm Concept Unique ID - RxCUI:
  • 312743
  • 317174
  • 312745
• UPC Code:
  • 0368001184083
  • 0368001182003
  • 0368001183062

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0054-0220	Quetiapine Fumarate	Quetiapine Fumarate
0054-0221	Quetiapine Fumarate	Quetiapine Fumarate
0054-0222	Quetiapine Fumarate	Quetiapine Fumarate
0054-0223	Quetiapine Fumarate	Quetiapine Fumarate
0054-0229	Quetiapine Fumarate	Quetiapine Fumarate
0054-0230	Quetiapine Fumarate	Quetiapine Fumarate
67877-242	Quetiapine Fumarate	Quetiapine Fumarate
67877-249	Quetiapine Fumarate	Quetiapine Fumarate
67877-250	Quetiapine Fumarate	Quetiapine Fumarate
67877-246	Quetiapine Fumarate	Quetiapine Fumarate
67877-248	Quetiapine Fumarate	Quetiapine Fumarate
67877-245	Quetiapine Fumarate	Quetiapine Fumarate
67877-247	Quetiapine Fumarate	Quetiapine Fumarate
68001-183	Quetiapine fumarate	Quetiapine fumarate
68001-182	Quetiapine fumarate	Quetiapine fumarate
68001-184	Quetiapine fumarate	Quetiapine fumarate
68001-180	Quetiapine fumarate	Quetiapine fumarate
68001-185	Quetiapine fumarate	Quetiapine fumarate
68001-181	Quetiapine fumarate	Quetiapine fumarate
68071-1892	Quetiapine Fumarate	Quetiapine Fumarate
68180-450	Quetiapine fumarate	Quetiapine fumarate
68180-447	Quetiapine fumarate	Quetiapine fumarate
68180-448	Quetiapine fumarate	Quetiapine fumarate
68151-5225	Quetiapine Fumarate	Quetiapine Fumarate
68180-614	Quetiapine fumarate	Quetiapine fumarate
68180-613	Quetiapine fumarate	Quetiapine fumarate
68180-615	Quetiapine fumarate	Quetiapine fumarate
68180-616	Quetiapine fumarate	Quetiapine fumarate
68180-445	Quetiapine fumarate	Quetiapine fumarate
68180-446	Quetiapine fumarate	Quetiapine fumarate
68180-612	Quetiapine fumarate	Quetiapine fumarate
68180-449	Quetiapine fumarate	Quetiapine fumarate
68788-7195	Quetiapine fumarate	Quetiapine fumarate
68788-9487	Quetiapine fumarate	Quetiapine fumarate
68788-9490	Quetiapine Fumarate	Quetiapine Fumarate
69189-0495	Quetiapine Fumarate	Quetiapine Fumarate
69189-0580	Quetiapine Fumarate	Quetiapine Fumarate
70518-0753	quetiapine fumarate	quetiapine fumarate
70518-0767	Quetiapine fumarate	Quetiapine fumarate
70518-0556	Quetiapine fumarate	Quetiapine fumarate
70518-0638	Quetiapine Fumarate	Quetiapine Fumarate
70518-0594	Quetiapine fumarate	Quetiapine fumarate
70518-0645	Quetiapine Fumarate	Quetiapine Fumarate
70518-0974	Quetiapine Fumarate	Quetiapine Fumarate
70518-1018	Quetiapine Fumarate	Quetiapine Fumarate
70518-1029	quetiapine fumarate	quetiapine fumarate
70518-0975	Quetiapine Fumarate	Quetiapine Fumarate
70518-0989	Quetiapine Fumarate	Quetiapine Fumarate
70518-0723	Quetiapine Fumarate	Quetiapine Fumarate
70518-0988	Quetiapine fumarate	Quetiapine fumarate