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United States · US · US:0299-3849_253b7408-3fad-49ca-e063-6294a90af64e

CLOBEX

Orange BookUNIISPLATC D07AD01

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

Identification

ManufacturerGalderma Laboratories, L.P.
CountryUS (United States)
ATC codeD07AD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0299384901
    1 BOTTLE in 1 CARTON (0299-3849-01) / 10 mL in 1 BOTTLE
  • ndc11
    0299384902
    1 BOTTLE in 1 CARTON (0299-3849-02) / 59 mL in 1 BOTTLE
  • ndc11
    0299384904
    1 BOTTLE in 1 CARTON (0299-3849-04) / 125 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
779619577M
CLOBETASOL PROPIONATE
RxCUI 21245
Orange Book
N021835
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "779619577M",
    "rxcui": "21245",
    "inchikey": "CBGUOGMQLZIXBE-XGQKBEPLSA-N",
    "display_name": "CLOBETASOL PROPIONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "acb3a25e-5746-4df6-89fd-cf3023e755cc": {
      "match": "brand_token",
      "title": "CLOBEX (CLOBETASOL PROPIONATE) SHAMPOO [GALDERMA LABORATORIES, L.P.]",
      "spl_version": "17",
      "published_date": "2025-08-27"
    }
  },
  "productid": "0299-3849_253b7408-3fad-49ca-e063-6294a90af64e",
  "productndc": "0299-3849",
  "dosage_form": "SPRAY",
  "orange_book": {
    "appl_no": "021835",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Oct 27, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOBETASOL PROPIONATE",
  "proprietary_name": "CLOBEX",
  "active_ingred_unit": "g/mL",
  "application_number": "NDA021835",
  "marketing_category": "NDA",
  "nonproprietary_name": "clobetasol propionate",
  "start_marketing_date": "20051027",
  "active_numerator_strength": ".05"
}

Related drugs

Other records sharing ATC code D07AD01.

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