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United States · US · US:69292-265_e96671e2-f7a8-4d58-8b7f-35b9b7fab5a6

Pilocarpine Hydrochloride

In shortageOrange BookUNIISPLATC N07AX01

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

Identification

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

Packs · 1

  • ndc11
    6929226501
    100 TABLET, FILM COATED in 1 BOTTLE (69292-265-01)

Annotations

UNII (FDA Substance ID)
0WW6D218XJ
PILOCARPINE HYDROCHLORIDE
RxCUI 235426
Orange Book
A076963
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": "69292-265_e96671e2-f7a8-4d58-8b7f-35b9b7fab5a6",
  "productndc": "69292-265",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076963",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 22, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "002",
        "approval_date": "Feb 27, 2007"
      }
    ],
    "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": "ANDA076963",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PILOCARPINE HYDROCHLORIDE",
  "start_marketing_date": "20220726",
  "active_numerator_strength": "5"
}

Related drugs

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