EPIPEN JR

In shortageOrange BookUNIISPLATC R03AA01

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

Identification

ManufacturerViatris Specialty LLC

CountryUS (United States)

ATC codeR03AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4950250102
2 CONTAINER in 1 CARTON (49502-501-02) / 1 SYRINGE, GLASS in 1 CONTAINER (49502-501-01) / .3 mL in 1 SYRINGE, GLASS
ndc11
4950250192
2 CONTAINER in 1 CARTON (49502-501-92) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)

YKH834O4BH

EPINEPHRINE

RxCUI 3992

Orange Book

N019430

ABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Epinephrine Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "YKH834O4BH",
    "rxcui": "3992",
    "inchikey": "UCTWMZQNUQWSLP-VIFPVBQESA-N",
    "display_name": "EPINEPHRINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "7560c201-9246-487c-a13b-6295db04274a": {
      "match": "brand_token",
      "title": "EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [VIATRIS SPECIALTY LLC]",
      "spl_version": "37",
      "published_date": "2025-02-12"
    }
  },
  "productid": "49502-501_81569d26-e9b3-4c1d-ac34-8a4cf5b4a98b",
  "productndc": "49502-501",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "019430",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.3MG/DELIVERY",
        "product_no": "001",
        "approval_date": "Dec 22, 1987"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.15MG/DELIVERY",
        "product_no": "002",
        "approval_date": "Dec 22, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.3MG/DELIVERY",
        "product_no": "003",
        "approval_date": "Aug 3, 1995"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.15MG/DELIVERY",
        "product_no": "004",
        "approval_date": "Aug 3, 1995"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPINEPHRINE",
  "shortage_reason": "Epinephrine Injection",
  "shortage_status": "current",
  "proprietary_name": "EPIPEN JR",
  "active_ingred_unit": "mg/.3mL",
  "application_number": "NDA019430",
  "marketing_category": "NDA",
  "nonproprietary_name": "epinephrine",
  "start_marketing_date": "19871222",
  "active_numerator_strength": ".15"
}

Related drugs

Other records sharing ATC code R03AA01.

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