Source: FDA, National Drug Code (US) Revision Year: 2022
ADDERALL XR extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. ADDERALL XR contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)aspartate monohydrate. This results in a 3.1:1 mixture of dextro to levo- amphetamine base equivalent.
The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended release capsules are for oral administration. Adderall XR contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the ADDERALL (immediate-release) tablet formulation.
Each capsule contains:
| Capsule Strength | 5 mg | 10 mg | 15 mg | 20 mg | 25 mg | 30 mg |
|---|---|---|---|---|---|---|
| Dextroamphetamine Saccharate | 1.25 mg | 2.5 mg | 3.75 mg | 5.0 mg | 6.25 mg | 7.5 mg |
| Amphetamine (D,L)-Aspartate Monohydrate | 1.25 mg | 2.5 mg | 3.75 mg | 5.0 mg | 6.25 mg | 7.5 mg |
| Dextroamphetamine Sulfate | 1.25 mg | 2.5 mg | 3.75 mg | 5.0 mg | 6.25 mg | 7.5 mg |
| Amphetamine Sulfate | 1.25 mg | 2.5 mg | 3.75 mg | 5.0 mg | 6.25 mg | 7.5 mg |
| Total amphetamine base equivalence | 3.1 mg | 6.3 mg | 9.4 mg | 12.5 mg | 15.6 mg | 18.8 mg |
| d-amphetamine base equivalence | 2.4 mg | 4.7 mg | 7.1 mg | 9.5 mg | 11.9 mg | 14.2 mg |
| l-amphetamine base equivalence | 0.75 mg | 1.5 mg | 2.3 mg | 3.0 mg | 3.8 mg | 4.5 mg |
The inactive ingredients in ADDERALL XR extended release capsules include: gelatin capsules, hydroxypropyl methylcellulose, methacrylic acid copolymer, opadry beige, sugar spheres, talc, and triethyl citrate. Gelatin capsules contain edible inks, kosher gelatin, and titanium dioxide. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #2. The 20 mg, 25 mg, and 30 mg capsules also contain red iron oxide and yellow iron oxide.
| Dosage Forms and Strengths |
|---|
|
ADDERALL XR 5 mg extended release capsules: Clear/blue (imprinted ADDERALL XR 5 mg). ADDERALL XR 10 mg extended release capsules: Blue/blue (imprinted ADDERALL XR 10 mg). ADDERALL XR 15 mg extended release capsules: Blue/white (imprinted ADDERALL XR 15 mg). ADDERALL XR 20 mg extended release capsules: Orange/orange (imprinted ADDERALL XR 20 mg). ADDERALL XR 25 mg extended release capsules: Orange/white (imprinted ADDERALL XR 25 mg). ADDERALL XR 30 mg extended release capsules: Natural/orange (imprinted ADDERALL XR 30 mg). |
| How Supplied |
|---|
|
ADDERALL XR 5 mg extended release capsules: Clear/blue (imprinted ADDERALL XR 5 mg), bottles of 100, NDC 54092-381-01 ADDERALL XR 10 mg extended release capsules: Blue/blue (imprinted ADDERALL XR 10 mg), bottles of 100, NDC 54092-383-01 ADDERALL XR 15 mg extended release capsules: Blue/white (imprinted ADDERALL XR 15 mg), bottles of 100, NDC 54092-385-01 ADDERALL XR 20 mg extended release capsules: Orange/orange (imprinted ADDERALL XR 20 mg), bottles of 100, NDC 54092-387-01 ADDERALL XR 25 mg extended release capsules: Orange/white (imprinted ADDERALL XR 25 mg), bottles of 100, NDC 54092-389-01 ADDERALL XR 30 mg extended release capsules: Natural/orange (imprinted ADDERALL XR 30 mg), bottles of 100, NDC 54092-391-01 Distributed by Takeda Pharmaceuticals America, Inc., Lexington, MA 02421, Made in USA |
| Drug | Countries | |
|---|---|---|
| ADDERALL | Canada, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
