tizanidine

Orange BookUNIISPLATC M03BX02

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeM03BX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
7161077616
6000 TABLET in 1 BOTTLE (71610-776-16)
ndc11
7161077630
30 TABLET in 1 BOTTLE (71610-776-30)
ndc11
7161077653
60 TABLET in 1 BOTTLE (71610-776-53)
ndc11
7161077660
90 TABLET in 1 BOTTLE (71610-776-60)
ndc11
7161077670
120 TABLET in 1 BOTTLE (71610-776-70)
ndc11
7161077675
7500 TABLET in 1 BOTTLE (71610-776-75)
ndc11
7161077680
180 TABLET in 1 BOTTLE (71610-776-80)

Annotations

UNII (FDA Substance ID)

B53E3NMY5C

TIZANIDINE HYDROCHLORIDE

RxCUI 236460

Orange Book

A076533

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": "71610-776_2cee3817-e6f6-9db6-e063-6294a90a6ea1",
  "productndc": "71610-776",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076533",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE",
        "product_no": "001",
        "approval_date": "Jan 16, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "002",
        "approval_date": "Jan 16, 2004"
      }
    ],
    "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": "ANDA076533",
  "marketing_category": "ANDA",
  "nonproprietary_name": "tizanidine",
  "start_marketing_date": "20040116",
  "active_numerator_strength": "4"
}

Related drugs

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