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United States · US · US:62135-205_4cb57dfc-1ebf-8510-e063-6294a90a31fc

Methimazole

Orange BookUNIISPLATC H03BB52

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

Identification

ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeH03BB52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6213520501
    100 TABLET in 1 BOTTLE (62135-205-01)
  • ndc11
    6213520505
    500 TABLET in 1 BOTTLE (62135-205-05)
  • ndc11
    6213520518
    180 TABLET in 1 BOTTLE (62135-205-18)
  • ndc11
    6213520530
    30 TABLET in 1 BOTTLE (62135-205-30)
  • ndc11
    6213520590
    90 TABLET in 1 BOTTLE (62135-205-90)

Annotations

UNII (FDA Substance ID)
554Z48XN5E
METHIMAZOLE
RxCUI 6835
Orange Book
A040411
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "554Z48XN5E",
    "rxcui": "6835",
    "inchikey": "PMRYVIKBURPHAH-UHFFFAOYSA-N",
    "display_name": "METHIMAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "06bb4bcc-5e47-48b6-a76c-648f846704e8": {
      "match": "brand_token",
      "title": "METHIMAZOLE TABLET [AIPING PHARMACEUTICAL, INC.]",
      "spl_version": "1",
      "published_date": "2026-04-02"
    }
  },
  "productid": "62135-205_4cb57dfc-1ebf-8510-e063-6294a90a31fc",
  "productndc": "62135-205",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040411",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Mar 27, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Mar 27, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHIMAZOLE",
  "proprietary_name": "Methimazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040411",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methimazole",
  "start_marketing_date": "20010327",
  "active_numerator_strength": "5"
}

Related drugs

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