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United States · US · US:59212-705_5e2a19b9-0694-43ac-9e0e-b40048495a1b

Salagen

In shortageOrange BookUNIISPLATC N07AX01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAdvanz Pharma (US) Corp.
CountryUS (United States)
ATC codeN07AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5921270510
    100 TABLET, FILM COATED in 1 BOTTLE (59212-705-10)

Annotations

UNII (FDA Substance ID)
0WW6D218XJ
PILOCARPINE HYDROCHLORIDE
RxCUI 235426
Orange Book
N020237
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Pilocarpine Hydrochloride Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "0WW6D218XJ",
    "rxcui": "235426",
    "inchikey": "RNAICSBVACLLGM-GNAZCLTHSA-N",
    "display_name": "PILOCARPINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "62eda83d-d043-4c7e-8fcf-75d05efbf35b": {
      "match": "brand_token",
      "title": "SALAGEN (PILOCARPINE HYDROCHLORIDE) TABLET, FILM COATED [ADVANZ PHARMA (US) CORP.]",
      "spl_version": "4",
      "published_date": "2024-12-20"
    }
  },
  "productid": "59212-705_5e2a19b9-0694-43ac-9e0e-b40048495a1b",
  "productndc": "59212-705",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020237",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Mar 22, 1994"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "002",
        "approval_date": "Apr 18, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PILOCARPINE HYDROCHLORIDE",
  "shortage_reason": "Pilocarpine Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Salagen",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020237",
  "marketing_category": "NDA",
  "nonproprietary_name": "Pilocarpine Hydrochloride",
  "start_marketing_date": "20190901",
  "active_numerator_strength": "5"
}

Related drugs

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