Clindamycin Palmitate Hydrochloride (Pediatric)

In shortageOrange BookUNIISPLATC G01AA10

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

Identification

ManufacturerNorthStar Rx LLC

CountryUS (United States)

ATC codeG01AA10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
1671448301
1 BOTTLE in 1 CARTON (16714-483-01) / 100 mL in 1 BOTTLE
ndc11
1671448302
1 BOTTLE, PLASTIC in 1 CARTON (16714-483-02) / 100 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

VN9A8JM7M7

CLINDAMYCIN PALMITATE HYDROCHLORIDE

RxCUI 91075

Orange Book

A202409

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": {
    "27747e01-85eb-44de-a4a6-711a7799218a": {
      "match": "brand_token",
      "title": "CLINDAMYCIN PHOSPHATE SOLUTION [BRYANT RANCH PREPACK]",
      "spl_version": "111",
      "published_date": "2026-06-01"
    }
  },
  "productid": "16714-483_366c8a71-1c5c-47e8-989d-d04503c65f4b",
  "productndc": "16714-483",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "202409",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 75MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Apr 30, 2013"
      }
    ],
    "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": "Clindamycin Palmitate Hydrochloride (Pediatric)",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA202409",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clindamycin Palmitate Hydrochloride (Pediatric)",
  "start_marketing_date": "20130430",
  "active_numerator_strength": "75"
}

Related drugs

Other records sharing ATC code G01AA10.

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