Amphetamine Sulfate

In shortageOrange BookUNIISPLATC N06BA01

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC

CountryUS (United States)

ATC codeN06BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6923815631
100 TABLET in 1 BOTTLE (69238-1563-1)

Annotations

UNII (FDA Substance ID)

6DPV8NK46S

AMPHETAMINE SULFATE

RxCUI 81952

Orange Book

A211139

AAAA

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": "6DPV8NK46S",
    "rxcui": "81952",
    "inchikey": "PYHRZPFZZDCOPH-UHFFFAOYSA-N",
    "display_name": "AMPHETAMINE SULFATE",
    "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": "69238-1563_940571ac-35e3-426e-8eb0-386a3987c3b9",
  "productndc": "69238-1563",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211139",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Sep 26, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Sep 26, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMPHETAMINE SULFATE",
  "shortage_reason": "Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Amphetamine Sulfate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211139",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amphetamine",
  "start_marketing_date": "20180928",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N06BA01.

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