Clindamycin Phosphate

In shortageOrange BookUNIISPLATC G01AA10

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

Identification

ManufacturerPadagis Israel Pharmaceuticals Ltd

CountryUS (United States)

ATC codeG01AA10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4580256201
1 BOTTLE, WITH APPLICATOR in 1 CARTON (45802-562-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR
ndc11
4580256202
1 BOTTLE, WITH APPLICATOR in 1 CARTON (45802-562-02) / 60 mL in 1 BOTTLE, WITH APPLICATOR
ndc11
4580256230
30 mL in 1 BOTTLE, WITH APPLICATOR (45802-562-30)
ndc11
4580256260
60 mL in 1 BOTTLE, WITH APPLICATOR (45802-562-60)

Annotations

UNII (FDA Substance ID)

EH6D7113I8

CLINDAMYCIN PHOSPHATE

RxCUI 797272

Orange Book

A064050

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": "45802-562_269f799d-6d9e-4643-87f7-97c30425e876",
  "productndc": "45802-562",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "064050",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AT",
        "strength": "EQ 1% BASE",
        "product_no": "001",
        "approval_date": "Nov 30, 1995"
      }
    ],
    "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/mL",
  "application_number": "ANDA064050",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clindamycin Phosphate",
  "start_marketing_date": "20130917",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code G01AA10.

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