ConZip
These highlights do not include all the information needed to use CONZIP safely and effectively. See full prescribing information for CONZIP. CONZIP (tramadol hydrochloride) extended-release capsules for oral use, CIV Initial U.S. Approval: 1995
Approved
Approval ID
a65b4d05-3a1c-4aa1-848a-d20ac9aaf62f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2023
Manufacturers
FDA
Vertical Pharmaceuticals, LLC
DUNS: 173169017
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tramadol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68025-072
Application NumberNDA022370
Product Classification
M
Marketing Category
C73594
G
Generic Name
tramadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (17)
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
TRAMADOL HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
D&C RED NO. 7Inactive
Code: ECW0LZ41X8
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSE STEARATEInactive
Code: 274KW0O50M
Classification: IACT
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive
Code: P2OM2Q86BI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
tramadol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68025-071
Application NumberNDA022370
Product Classification
M
Marketing Category
C73594
G
Generic Name
tramadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (16)
TRAMADOL HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive
Code: P2OM2Q86BI
Classification: IACT
SUCROSE STEARATEInactive
Code: 274KW0O50M
Classification: IACT
tramadol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68025-073
Application NumberNDA022370
Product Classification
M
Marketing Category
C73594
G
Generic Name
tramadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (17)
D&C RED NO. 7Inactive
Code: ECW0LZ41X8
Classification: IACT
TRAMADOL HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SUCROSE STEARATEInactive
Code: 274KW0O50M
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive
Code: P2OM2Q86BI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT