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United States · US · US:0009-0760_b53fb12e-75af-47c6-8777-0e8f1e36c47f

Cleocin Pediatric

In shortageOrange BookUNIISPLATC G01AA10

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

Identification

ManufacturerPharmacia & Upjohn Company LLC
CountryUS (United States)
ATC codeG01AA10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0009076012
    1 BOTTLE in 1 CARTON (0009-0760-12) / 100 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
VN9A8JM7M7
CLINDAMYCIN PALMITATE HYDROCHLORIDE
RxCUI 91075
Orange Book
A062644
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Clindamycin Phosphate; Benzoyl Peroxide Gel
Raw payload (JSON)
{
  "unii": {
    "unii": "VN9A8JM7M7",
    "rxcui": "91075",
    "inchikey": "GTNDZRUWKHDICY-DJHAJVGHSA-N",
    "display_name": "CLINDAMYCIN PALMITATE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b": {
      "match": "brand_token",
      "title": "CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]",
      "spl_version": "15",
      "published_date": "2026-05-21"
    }
  },
  "productid": "0009-0760_b53fb12e-75af-47c6-8777-0e8f1e36c47f",
  "productndc": "0009-0760",
  "dosage_form": "GRANULE, FOR SOLUTION",
  "orange_book": {
    "appl_no": "062644",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 75MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Apr 7, 1986"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLINDAMYCIN PALMITATE HYDROCHLORIDE",
  "shortage_reason": "Clindamycin Phosphate; Benzoyl Peroxide Gel",
  "shortage_status": "current",
  "proprietary_name": "Cleocin Pediatric",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA062644",
  "marketing_category": "ANDA",
  "nonproprietary_name": "clindamycin palmitate hydrochloride",
  "start_marketing_date": "19860417",
  "active_numerator_strength": "75"
}

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