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United States · US · US:0168-0202_cb48e014-0b84-4c84-867e-50c0f698340d

clindamycin phosphate

In shortageOrange BookUNIISPLATC G01AA10

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

Identification

ManufacturerE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
CountryUS (United States)
ATC codeG01AA10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0168020230
    1 TUBE in 1 CARTON (0168-0202-30) / 30 g in 1 TUBE
  • ndc11
    0168020260
    1 TUBE in 1 CARTON (0168-0202-60) / 60 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
EH6D7113I8
CLINDAMYCIN PHOSPHATE
RxCUI 797272
Orange Book
A064160
AB1
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Clindamycin Palmitate Hydrochloride Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "EH6D7113I8",
    "rxcui": "797272",
    "inchikey": "UFUVLHLTWXBHGZ-MGZQPHGTSA-N",
    "display_name": "CLINDAMYCIN PHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "27747e01-85eb-44de-a4a6-711a7799218a": {
      "match": "brand_token",
      "title": "CLINDAMYCIN PHOSPHATE SOLUTION [BRYANT RANCH PREPACK]",
      "spl_version": "111",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0168-0202_cb48e014-0b84-4c84-867e-50c0f698340d",
  "productndc": "0168-0202",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "064160",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "EQ 1% BASE",
        "product_no": "001",
        "approval_date": "Jan 28, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLINDAMYCIN PHOSPHATE",
  "shortage_reason": "Clindamycin Palmitate Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "clindamycin phosphate",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA064160",
  "marketing_category": "ANDA",
  "nonproprietary_name": "clindamycin phosphate",
  "start_marketing_date": "20000128",
  "active_numerator_strength": "10"
}

Related drugs

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