Pilocarpine Hydrochloride

In shortageOrange BookUNIISPLATC N07AX01

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

Identification

ManufacturerSomerset Therapeutics, LLC

CountryUS (United States)

ATC codeN07AX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7006920101
1 BOTTLE in 1 CARTON (70069-201-01) / 15 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

0WW6D218XJ

PILOCARPINE HYDROCHLORIDE

RxCUI 235426

Orange Book

A210384

ATATAT

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": "70069-201_82a2d0b0-5ac5-46a1-b945-1f5669cc75ec",
  "productndc": "70069-201",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "210384",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Nov 25, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "2%",
        "product_no": "002",
        "approval_date": "Nov 25, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "4%",
        "product_no": "003",
        "approval_date": "Nov 25, 2019"
      }
    ],
    "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",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA210384",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pilocarpine Hydrochloride Ophthalmic Solution",
  "start_marketing_date": "20191125",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code N07AX01.

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