Back to search
🇺🇸

United States · US · US:68084-928_4911bf7f-0c0c-fde7-e063-6394a90ac636

Pilocarpine hydrochloride

In shortageOrange BookUNIISPLATC N07AX01

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

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeN07AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6808492825
    30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-928-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-928-95)

Annotations

UNII (FDA Substance ID)
0WW6D218XJ
PILOCARPINE HYDROCHLORIDE
RxCUI 235426
Orange Book
N020237
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": "68084-928_4911bf7f-0c0c-fde7-e063-6394a90ac636",
  "productndc": "68084-928",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020237",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Mar 22, 1994"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "002",
        "approval_date": "Apr 18, 2003"
      }
    ],
    "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": "Pilocarpine hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020237",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Pilocarpine hydrochloride",
  "start_marketing_date": "20150925",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N07AX01.

Access this data programmatically

Query Pilocarpine hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.