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United States · US · US:76420-885_2a395a10-4c73-4213-e063-6394a90abb25

tizanidine

Orange BookUNIISPLATC M03BX02

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

Identification

ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeM03BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    7642088500
    1000 TABLET in 1 BOTTLE (76420-885-00)
  • ndc11
    7642088501
    100 TABLET in 1 BOTTLE (76420-885-01)
  • ndc11
    7642088511
    10 TABLET in 1 BLISTER PACK (76420-885-11)
  • ndc11
    7642088515
    15 TABLET in 1 BOTTLE (76420-885-15)
  • ndc11
    7642088521
    150 TABLET in 1 BOTTLE (76420-885-21)
  • ndc11
    7642088530
    30 TABLET in 1 BOTTLE (76420-885-30)
  • ndc11
    7642088560
    60 TABLET in 1 BOTTLE (76420-885-60)
  • ndc11
    7642088588
    10 TABLET in 1 BOTTLE (76420-885-88)
  • ndc11
    7642088590
    90 TABLET in 1 BOTTLE (76420-885-90)
  • ndc11
    7642088599
    10 BLISTER PACK in 1 CARTON (76420-885-99) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
B53E3NMY5C
TIZANIDINE HYDROCHLORIDE
RxCUI 236460
Orange Book
A208187
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "B53E3NMY5C",
    "rxcui": "236460",
    "inchikey": "ZWUKMNZJRDGCTQ-UHFFFAOYSA-N",
    "display_name": "TIZANIDINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "22ea819a-2aaa-44e0-a350-258541b11220": {
      "match": "brand_token",
      "title": "TIZANIDINE HYDROCHLORIDE CAPSULE [KANCHAN HEALTHCARE INC]",
      "spl_version": "9",
      "published_date": "2026-05-21"
    }
  },
  "productid": "76420-885_2a395a10-4c73-4213-e063-6394a90abb25",
  "productndc": "76420-885",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208187",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Mar 9, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Mar 9, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIZANIDINE HYDROCHLORIDE",
  "proprietary_name": "tizanidine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208187",
  "marketing_category": "ANDA",
  "nonproprietary_name": "tizanidine",
  "start_marketing_date": "20210304",
  "active_numerator_strength": "2"
}

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