Tizanidine Hydrochloride

Orange BookUNIISPLATC M03BX02

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeM03BX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7642090001
1 BLISTER PACK in 1 CARTON (76420-900-01) / 10 CAPSULE in 1 BLISTER PACK
ndc11
7642090005
500 CAPSULE in 1 BOTTLE (76420-900-05)
ndc11
7642090010
10 CAPSULE in 1 BOTTLE (76420-900-10)
ndc11
7642090015
150 CAPSULE in 1 BOTTLE (76420-900-15)
ndc11
7642090020
20 CAPSULE in 1 BOTTLE (76420-900-20)
ndc11
7642090030
30 CAPSULE in 1 BOTTLE (76420-900-30)
ndc11
7642090060
60 CAPSULE in 1 BOTTLE (76420-900-60)
ndc11
7642090090
90 CAPSULE in 1 BOTTLE (76420-900-90)

Annotations

UNII (FDA Substance ID)

B53E3NMY5C

TIZANIDINE HYDROCHLORIDE

RxCUI 236460

Orange Book

A212196

ABABAB

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": "76420-900_4647720a-9159-6041-e063-6294a90a54f1",
  "productndc": "76420-900",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "212196",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Mar 27, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Mar 27, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 6MG BASE",
        "product_no": "003",
        "approval_date": "Mar 27, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIZANIDINE HYDROCHLORIDE",
  "proprietary_name": "Tizanidine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212196",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tizanidine Hydrochloride",
  "start_marketing_date": "20190329",
  "active_numerator_strength": "2"
}

Related drugs

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