MedPath
FDA Product

ConZip

Product approved by U.S. Food and Drug Administration (US)

Basic Information

ConZip

68025-071

Regulatory Information

68025-071

NDA022370

C73594

December 22, 2023

USA

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

HUMAN PRESCRIPTION DRUG LABEL

13

Company Information

173169017

Active Ingredients

TRAMADOL HYDROCHLORIDE

Quantity: 100 mg in 1 1

Code: 9N7R477WCK

Class Code: ACTIB

SODIUM STARCH GLYCOLATE TYPE A

Code: H8AV0SQX4D

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)

Code: P2OM2Q86BI

Class Code: IACT

SUCROSE STEARATE

Code: 274KW0O50M

Class Code: IACT

Active Moieties

TRAMADOL

Code: 39J1LGJ30J

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