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United States · US · US:0264-9378_5f189f9b-1978-401e-8e5f-1969fe8c8ad7

LIDOCAINE HCl and EPINEPHRINE

In shortageOrange BookUNIISPLATC A01AD

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

Identification

ManufacturerB. Braun Medical Inc.
CountryUS (United States)
ATC codeA01AD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0264937805
    5 AMPULE in 1 CARTON (0264-9378-05) / 5 mL in 1 AMPULE (0264-9378-88)

Annotations

UNII (FDA Substance ID)
30Q7KI53AK
EPINEPHRINE BITARTRATE
RxCUI 203180
Orange Book
A208475
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Epinephrine Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "30Q7KI53AK",
    "rxcui": "203180",
    "inchikey": "YLXIPWWIOISBDD-NDAAPVSOSA-N",
    "display_name": "EPINEPHRINE BITARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
  "spl_meta": {
    "4db609cc-f329-62a4-e063-6394a90aefc1": {
      "match": "brand_token",
      "title": "LIDOCAINE GEL [YYBA CORP]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0264-9378_5f189f9b-1978-401e-8e5f-1969fe8c8ad7",
  "productndc": "0264-9378",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "208475",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.005MG/ML;1.5%",
        "product_no": "001",
        "approval_date": "Sep 8, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS",
  "shortage_reason": "Epinephrine Injection",
  "shortage_status": "current",
  "proprietary_name": "LIDOCAINE HCl and EPINEPHRINE",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA208475",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LIDOCAINE HCl and EPINEPHRINE",
  "start_marketing_date": "20210908",
  "active_numerator_strength": ".005; 15"
}

Related drugs

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