Pilocarpine Hydrochloride Ophthalmic

In shortageOrange BookUNIISPLATC N07AX01

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

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
6021923662
1 BOTTLE, DROPPER in 1 CARTON (60219-2366-2) / 2.5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)

0WW6D218XJ

PILOCARPINE HYDROCHLORIDE

RxCUI 235426

Orange Book

A217733

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Pilocarpine Hydrochloride Ophthalmic Solution

Raw payload (JSON)

{
  "unii": {
    "unii": "0WW6D218XJ",
    "rxcui": "235426",
    "inchikey": "RNAICSBVACLLGM-GNAZCLTHSA-N",
    "display_name": "PILOCARPINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "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": "60219-2366_a804f045-c81b-469d-848d-475bf8aac237",
  "productndc": "60219-2366",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "217733",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "1.25%",
        "product_no": "001",
        "approval_date": "Apr 28, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PILOCARPINE HYDROCHLORIDE",
  "shortage_reason": "Pilocarpine Hydrochloride Ophthalmic Solution",
  "shortage_status": "current",
  "proprietary_name": "Pilocarpine Hydrochloride Ophthalmic",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA217733",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pilocarpine Hydrochloride",
  "start_marketing_date": "20250501",
  "active_numerator_strength": "12.5"
}

Related drugs

Other records sharing ATC code N07AX01.

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