NDC 54348-989

Prochlorperazine

Prochlorperazine

Prochlorperazine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pharmpak, Inc.. The primary component is Prochlorperazine Maleate.

Product ID54348-989_8f76c341-a3b7-7d4e-e053-2995a90a6aea
NDC54348-989
Product TypeHuman Prescription Drug
Proprietary NameProchlorperazine
Generic NameProchlorperazine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-11
Marketing CategoryANDA / ANDA
Application NumberANDA040268
Labeler NamePharmPak, Inc.
Substance NamePROCHLORPERAZINE MALEATE
Active Ingredient Strength5 mg/1
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54348-989-06

1 BOTTLE in 1 BOX (54348-989-06) > 6 TABLET in 1 BOTTLE
Marketing Start Date2019-07-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54348-989-06 [54348098906]

Prochlorperazine TABLET
Marketing CategoryANDA
Application NumberANDA040268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

Drug Details

Active Ingredients

IngredientStrength
PROCHLORPERAZINE MALEATE5 mg/1

OpenFDA Data

SPL SET ID:383744db-ba57-478a-8041-2ecc26d3e1ec
Manufacturer
UNII

Pharmacological Class

  • Phenothiazine [EPC]
  • Phenothiazines [CS]
  • Phenothiazine [EPC]
  • Phenothiazines [CS]

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

NDCBrand NameGeneric Name
0713-0135ProchlorperazineProchlorperazine
50090-0636ProchlorperazineProchlorperazine
54348-114PROCHLORPERAZINEPROCHLORPERAZINE
54348-989ProchlorperazinePROCHLORPERAZINE
66267-176ProchlorperazineProchlorperazine
68071-3259ProchlorperazineProchlorperazine
66213-200CompazineProchlorperazine
0574-7226ComproPROCHLORPERAZINE
50090-2881ComproPROCHLORPERAZINE
55289-119ComproPROCHLORPERAZINE
63629-8444ComproPROCHLORPERAZINE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.