DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets CII Rx only
Approved
Approval ID
430cccec-1679-4225-8c86-92d746153b38
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 28, 2023
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-155
Application NumberANDA213709
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2023
FDA Product Classification
INGREDIENTS (11)
AMPHETAMINE SULFATEActive
Quantity: 1.25 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
DEXTROAMPHETAMINE SULFATEActive
Quantity: 1.25 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 1.25 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 1.25 mg in 1 1
Code: G83415V073
Classification: ACTIB
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-164
Application NumberANDA213709
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2023
FDA Product Classification
INGREDIENTS (12)
AMPHETAMINE SULFATEActive
Quantity: 7.5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
DEXTROAMPHETAMINE SULFATEActive
Quantity: 7.5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 7.5 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 7.5 mg in 1 1
Code: G83415V073
Classification: ACTIB
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-159
Application NumberANDA213709
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2023
FDA Product Classification
INGREDIENTS (12)
AMPHETAMINE SULFATEActive
Quantity: 3.75 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
DEXTROAMPHETAMINE SULFATEActive
Quantity: 3.75 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 3.75 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 3.75 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-156
Application NumberANDA213709
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2023
FDA Product Classification
INGREDIENTS (12)
AMPHETAMINE SULFATEActive
Quantity: 1.875 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 1.875 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 1.875 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 1.875 mg in 1 1
Code: G83415V073
Classification: ACTIB
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-157
Application NumberANDA213709
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2023
FDA Product Classification
INGREDIENTS (12)
DEXTROAMPHETAMINE SULFATEActive
Quantity: 2.5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
AMPHETAMINE SULFATEActive
Quantity: 2.5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 2.5 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 2.5 mg in 1 1
Code: G83415V073
Classification: ACTIB
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-163
Application NumberANDA213709
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2023
FDA Product Classification
INGREDIENTS (12)
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
AMPHETAMINE SULFATEActive
Quantity: 5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
DEXTROAMPHETAMINE SULFATEActive
Quantity: 5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 5 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 5 mg in 1 1
Code: G83415V073
Classification: ACTIB
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-158
Application NumberANDA213709
Product Classification
M
Marketing Category
C73584
G
Generic Name
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2023
FDA Product Classification
INGREDIENTS (12)
DEXTROAMPHETAMINE SULFATEActive
Quantity: 3.125 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
AMPHETAMINE SULFATEActive
Quantity: 3.125 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 3.125 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 3.125 mg in 1 1
Code: G83415V073
Classification: ACTIB