Amphetamine

In shortageOrange BookUNIISPLATC N06BA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTeva Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN06BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0480332065
30 BLISTER PACK in 1 CARTON (0480-3320-65) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

CK833KGX7E

AMPHETAMINE

RxCUI 725

Orange Book

A209253

ABABABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "CK833KGX7E",
    "rxcui": "725",
    "inchikey": "KWTSXDURSIMDCE-UHFFFAOYSA-N",
    "display_name": "AMPHETAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "920f99f4-ab78-4eed-9d80-08a2ebd0b769": {
      "match": "brand_token",
      "title": "AMPHETAMINE SULFATE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "3",
      "published_date": "2026-04-02"
    }
  },
  "productid": "0480-3320_4373ba4a-1fee-46df-bba9-b60e42cfd15a",
  "productndc": "0480-3320",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "209253",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 3.1MG BASE",
        "product_no": "001",
        "approval_date": "Jun 22, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 6.3MG BASE",
        "product_no": "002",
        "approval_date": "Jun 22, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 9.4MG BASE",
        "product_no": "003",
        "approval_date": "Jun 22, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 12.5MG BASE",
        "product_no": "004",
        "approval_date": "Jun 22, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 15.7MG BASE",
        "product_no": "005",
        "approval_date": "Jun 22, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 18.8MG BASE",
        "product_no": "006",
        "approval_date": "Jun 22, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMPHETAMINE",
  "shortage_reason": "Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Amphetamine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209253",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amphetamine",
  "start_marketing_date": "20251208",
  "active_numerator_strength": "18.8"
}

Related drugs

Other records sharing ATC code N06BA01.

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