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United States · US · US:60219-5922_83bbaf17-9d8e-494a-8e76-361550296b5e

Pilocarpine Hydrochloride

In shortageOrange BookUNIISPLATC N07AX01

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeN07AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6021959221
    100 TABLET, FILM COATED in 1 BOTTLE (60219-5922-1)

Annotations

UNII (FDA Substance ID)
0WW6D218XJ
PILOCARPINE HYDROCHLORIDE
RxCUI 235426
Orange Book
A077248
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": {
    "6272ccac-b543-404d-9938-8583bb59ed2c": {
      "match": "brand_token",
      "title": "PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]",
      "spl_version": "17",
      "published_date": "2026-04-27"
    }
  },
  "productid": "60219-5922_83bbaf17-9d8e-494a-8e76-361550296b5e",
  "productndc": "60219-5922",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077248",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Mar 31, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "002",
        "approval_date": "Mar 31, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PILOCARPINE HYDROCHLORIDE",
  "shortage_reason": "Pilocarpine Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Pilocarpine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077248",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PILOCARPINE HYDROCHLORIDE",
  "start_marketing_date": "20070501",
  "active_numerator_strength": "5"
}

Related drugs

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