Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate

In shortageOrange BookUNIISPLATC N06BA

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

Identification

ManufacturerGLENMARK PHARMACEUTICALS INC., USA

CountryUS (United States)

ATC codeN06BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6846264901
100 TABLET in 1 BOTTLE (68462-649-01)

Annotations

UNII (FDA Substance ID)

H527KAP6L5

AMPHETAMINE DL-ASPARTATE

RxCUI 221057

Orange Book

A210754

ABABABABAB

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": "H527KAP6L5",
    "rxcui": "221057",
    "inchikey": "DYOBNLAYPQSBLB-UHFFFAOYSA-N",
    "display_name": "AMPHETAMINE DL-ASPARTATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f6dfefdf-7a4a-e104-e053-6394a90a05bd": {
      "match": "brand_token",
      "title": "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE) CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "7",
      "published_date": "2026-06-01"
    }
  },
  "productid": "68462-649_a586519f-97a3-4a3a-951a-c3ecaab95334",
  "productndc": "68462-649",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210754",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.25MG;1.25MG;1.25MG;1.25MG",
        "product_no": "001",
        "approval_date": "Jul 5, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;2.5MG;2.5MG;2.5MG",
        "product_no": "002",
        "approval_date": "Jul 5, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3.75MG;3.75MG;3.75MG;3.75MG",
        "product_no": "003",
        "approval_date": "Jul 5, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;5MG;5MG;5MG",
        "product_no": "004",
        "approval_date": "Jul 5, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG;7.5MG;7.5MG;7.5MG",
        "product_no": "005",
        "approval_date": "Jul 5, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMPHETAMINE DL-ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
  "shortage_reason": "Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "ANDA210754",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate",
  "start_marketing_date": "20250512",
  "active_numerator_strength": "2.5; 2.5; 2.5; 2.5"
}

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