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  5. NDC Package Code: 0480-3686-01 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate

NDC Package 0480-3686-01 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate

Capsule, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0480-3686-01
Package Description:
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code:
0480-3686
Proprietary Name:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate
Non-Proprietary Name:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate
Substance Name:
Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate
Usage Information:
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see Clinical Studies (14)].Limitations of Use Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose, and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite [see Use in Specific Populations (8.4)].
11-Digit NDC Billing Format:
00480368601
NDC to RxNorm Crosswalk:
  • RxCUI: 1927610 - amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG 3-Bead 24HR Extended Release Oral Capsule
  • RxCUI: 1927610 - 3-Bead 24 HR amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG Extended Release Oral Capsule
  • RxCUI: 1927617 - amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG 3-Bead 24HR Extended Release Oral Capsule
  • RxCUI: 1927617 - 3-Bead 24 HR amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG Extended Release Oral Capsule
  • RxCUI: 1927630 - amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG 3-Bead 24HR Extended Release Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Teva Pharmaceuticals, Inc.
    Dosage Form:
    Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AMPHETAMINE ASPARTATE MONOHYDRATE 12.5 mg/1
  • AMPHETAMINE SULFATE 12.5 mg/1
  • DEXTROAMPHETAMINE SACCHARATE 12.5 mg/1
  • DEXTROAMPHETAMINE SULFATE 12.5 mg/1
    • Pharmacologic Class(es):
  • Central Nervous System Stimulant - [EPC] (Established Pharmacologic Class)
  • Central Nervous System Stimulant - [EPC] (Established Pharmacologic Class)
  • Central Nervous System Stimulation - [PE] (Physiologic Effect)
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA210876
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-10-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0480-3686-01?

    The NDC Packaged Code 0480-3686-01 is assigned to a package of 100 capsule, extended release in 1 bottle of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate, a human prescription drug labeled by Teva Pharmaceuticals, Inc.. The product's dosage form is capsule, extended release and is administered via oral form.

    Is NDC 0480-3686 included in the NDC Directory?

    Yes, Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate with product code 0480-3686 is active and included in the NDC Directory. The product was first marketed by Teva Pharmaceuticals, Inc. on October 10, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0480-3686-01?

    The 11-digit format is 00480368601. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20480-3686-015-4-200480-3686-01