PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE TABLETS, USPRx Only
Approved
Approval ID
a49905cc-dd53-43a2-8113-d8ada3f8cae9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prochlorperazine Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-571
Application NumberANDA040268
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prochlorperazine Maleate
Product Specifications
Route of AdministrationORAL
Effective DateJune 11, 2010
FDA Product Classification
INGREDIENTS (14)
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Prochlorperazine MaleateActive
Quantity: 5 mg in 1 1
Code: I1T8O1JTL6
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Polyethylene GlycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT
D&c Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Fd&c Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
Fd&c Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
Prochlorperazine maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-572
Application NumberANDA040268
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prochlorperazine maleate
Product Specifications
Route of AdministrationORAL
Effective DateJune 11, 2010
FDA Product Classification
INGREDIENTS (14)
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Polyethylene GlycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
Prochlorperazine MaleateActive
Quantity: 10 mg in 1 1
Code: I1T8O1JTL6
Classification: ACTIM
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
D&c Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Fd&c Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Fd&c Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT