VYVANSE Capsule / Tablet chewable Ref.[11110] Active ingredients: Lisdexamfetamine

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

VYVANSE (lisdexamfetamine dimesylate), a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C15H25N3O∙(CH4O3S)2, which corresponds to a molecular weight of 455.60.

The chemical structure is:

Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL).

Information for VYVANSE capsules

VYVANSE capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine).

Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The capsule shells contain gelatin, titanium dioxide, and one or more of the following: FD&C Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide.

Information for VYVANSE chewable tablets

VYVANSE chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of lisdexamfetamine).

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, sucralose, artificial strawberry flavor.

Dosage Forms and Strengths

Information for VYVANSE capsules:

  • Capsules 10 mg: pink body/pink cap (imprinted with S489 and 10 mg)
  • Capsules 20 mg: ivory body/ivory cap (imprinted with S489 and 20 mg)
  • Capsules 30 mg: white body/orange cap (imprinted with S489 and 30 mg)
  • Capsules 40 mg: white body/blue green cap (imprinted with S489 and 40 mg)
  • Capsules 50 mg: white body/blue cap (imprinted with S489 and 50 mg)
  • Capsules 60 mg: aqua blue body/aqua blue cap (imprinted with S489 and 60 mg)
  • Capsules 70 mg: blue body/orange cap (imprinted with S489 and 70 mg)

Information for VYVANSE chewable tablets:

  • Chewable tablets 10 mg: White to off-white round shaped tablet debossed with ‘10’ on one side and ‘S489’ on the other
  • Chewable tablets 20 mg: White to off-white hexagonal shaped tablet debossed with ‘20’ on one side and ‘S489’ on the other
  • Chewable tablets 30 mg: White to off-white arc triangular shaped tablet debossed with ‘30’ on one side and ‘S489’ on the other
  • Chewable tablets 40 mg: White to off-white capsule shaped tablet debossed with ‘40’ on one side and ‘S489’ on the other
  • Chewable tablets 50 mg: White to off-white arc square shaped tablet debossed with ‘50’ on one side and ‘S489’ on the other
  • Chewable tablets 60 mg: White to off-white arc diamond shaped tablet debossed with ‘60’ on one side and ‘S489’ on the other
How Supplied

Information for VYVANSE capsules:

  • VYVANSE capsules 10 mg: pink body/pink cap (imprinted with S489 and 10 mg), bottles of 100, NDC 59417-101-10
  • VYVANSE capsules 20 mg: ivory body/ivory cap (imprinted with S489 and 20 mg), bottles of 100, NDC 59417-102-10
  • VYVANSE capsules 30 mg: white body/orange cap (imprinted with S489 and 30 mg), bottles of 100, NDC 59417-103-10
  • VYVANSE capsules 40 mg: white body/blue green cap (imprinted with S489 and 40 mg), bottles of 100, NDC 59417-104-10
  • VYVANSE capsules 50 mg: white body/blue cap (imprinted with S489 and 50 mg), bottles of 100, NDC 59417-105-10
  • VYVANSE capsules 60 mg: aqua blue body/aqua blue cap (imprinted with S489 and 60 mg), bottles of 100, NDC 59417-106-10
  • VYVANSE capsules 70 mg: blue body/orange cap (imprinted with S489 and 70 mg), bottles of 100, NDC 59417-107-10

Information for VYVANSE chewable tablets:

  • VYVANSE chewable tablets 10 mg: White to off-white round shaped tablet debossed with ‘10’ on one side and ‘S489’ on the other, bottles of 100, NDC 59417-115-01
  • VYVANSE chewable tablets 20 mg: White to off-white hexagonal shaped tablet debossed with ‘20’ on one side and ‘S489’ on the other, bottles of 100, NDC 59417-116-01
  • VYVANSE chewable tablets 30 mg: White to off-white arc triangular shaped tablet debossed with ‘30’ on one side and ‘S489’ on the other, bottles of 100, NDC 59417-117-01
  • VYVANSE chewable tablets 40 mg: White to off-white capsule shaped tablet debossed with ‘40’ on one side and ‘S489’ on the other, bottles of 100, NDC 59417-118-01
  • VYVANSE chewable tablets 50 mg: White to off-white arc square shaped tablet debossed with ‘50’ on one side and ‘S489’ on the other, bottles of 100, NDC 59417-119-01
  • VYVANSE chewable tablets 60 mg: White to off-white arc diamond shaped tablet debossed with ‘60’ on one side and ‘S489’ on the other, bottles of 100, NDC 59417-120-01

Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421

Drugs

Drug Countries
VYVANSE Australia, Canada, Hong Kong, Israel, Japan, New Zealand, Singapore, United States
 
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