Qlosi

In shortageOrange BookUNIISPLATC N07AX01

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

Identification

ManufacturerOrasis Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN07AX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
8366101810
10 VIAL, SINGLE-USE in 1 BOX (83661-018-10) / .4 mL in 1 VIAL, SINGLE-USE
ndc11
8366101820
20 VIAL, SINGLE-USE in 1 BOX (83661-018-20) / .4 mL in 1 VIAL, SINGLE-USE
ndc11
8366101830
30 VIAL, SINGLE-USE in 1 BOX (83661-018-30) / .4 mL in 1 VIAL, SINGLE-USE
ndc11
8366101860
60 VIAL, SINGLE-USE in 1 BOX (83661-018-60) / .4 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)

0WW6D218XJ

PILOCARPINE HYDROCHLORIDE

RxCUI 235426

Orange Book

N217836

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": "OPHTHALMIC",
  "spl_meta": {
    "4ee2a840-1203-473a-aa42-316a3ddf2fbe": {
      "match": "brand_token",
      "title": "QLOSI (PILOCARPINE HYDROCHLORIDE) SOLUTION [ORASIS PHARMACEUTICALS, INC.]",
      "spl_version": "5",
      "published_date": "2025-06-02"
    }
  },
  "productid": "83661-018_35bee113-ab9f-605d-e063-6394a90ac5a2",
  "productndc": "83661-018",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "217836",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.4%",
        "product_no": "001",
        "approval_date": "Oct 17, 2023"
      }
    ],
    "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": "Qlosi",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA217836",
  "marketing_category": "NDA",
  "nonproprietary_name": "Pilocarpine Hydrochloride",
  "start_marketing_date": "20241015",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code N07AX01.

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