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United States · US · US:39822-0353_df369d62-f1a4-1a53-e053-2995a90abbf9

Lincomycin

In shortageOrange BookUNIISPLATC J01FF02

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

Identification

ManufacturerXGen Pharmaceuticals DJB, Inc.
CountryUS (United States)
ATC codeJ01FF02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3982203536
    10 mL in 1 VIAL (39822-0353-6)

Annotations

UNII (FDA Substance ID)
M6T05Z2B68
LINCOMYCIN HYDROCHLORIDE
RxCUI 82036
Orange Book
A201746
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Lincomycin Hydrochloride Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "M6T05Z2B68",
    "rxcui": "82036",
    "inchikey": "LFZGYTBWUHCAKF-DCNJEFSFSA-N",
    "display_name": "LINCOMYCIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL",
  "spl_meta": {
    "a7692968-7ac8-48ab-89a4-27c7803e31f4": {
      "match": "brand_token",
      "title": "LINCOMYCIN (LINCOMYCIN HYDROCHLORIDE) INJECTION, SOLUTION [HENRY SCHEIN, INC.]",
      "spl_version": "5",
      "published_date": "2025-11-17"
    }
  },
  "productid": "39822-0353_df369d62-f1a4-1a53-e053-2995a90abbf9",
  "productndc": "39822-0353",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "201746",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 300MG BASE/ML",
        "product_no": "001",
        "approval_date": "Jun 4, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LINCOMYCIN HYDROCHLORIDE",
  "shortage_reason": "Lincomycin Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Lincomycin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA201746",
  "marketing_category": "ANDA",
  "nonproprietary_name": "lincomycin hydrochloride",
  "start_marketing_date": "20150705",
  "active_numerator_strength": "300"
}

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