tizanidne hydrochloride

Generic: tizanidne hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidne hydrochloride
Generic Name tizanidne hydrochloride
Labeler asclemed usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 6 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-231
Product ID 76420-231_e347f58a-9fc4-7e64-e053-2a95a90a528b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212196
Listing Expiration 2026-12-31
Marketing Start 2019-03-29

Pharmacologic Class

Classes
adrenergic alpha2-agonists [moa] central alpha-2 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420231
Hyphenated Format 76420-231

Supplemental Identifiers

RxCUI
485484
UNII
B53E3NMY5C

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tizanidne hydrochloride (source: ndc)
Generic Name tizanidne hydrochloride (source: ndc)
Application Number ANDA212196 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (76420-231-30)
  • 60 CAPSULE in 1 BOTTLE (76420-231-60)
  • 90 CAPSULE in 1 BOTTLE (76420-231-90)
source: ndc

Packages (3)

76420-231-30 30 CAPSULE in 1 BOTTLE (76420-231-30) 76420-231-60 60 CAPSULE in 1 BOTTLE (76420-231-60) 76420-231-90 90 CAPSULE in 1 BOTTLE (76420-231-90)

Ingredients (1)

tizanidine hydrochloride (6 mg/1)

Linked Drug Pages (1)

Tizanidne hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e347f58a-9fc4-7e64-e053-2a95a90a528b", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["485484"], "spl_set_id": ["1ad6eaf6-bd32-4d05-bdd0-a6246e2afb9c"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (76420-231-30)", "package_ndc": "76420-231-30", "marketing_start_date": "20220707"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76420-231-60)", "package_ndc": "76420-231-60", "marketing_start_date": "20220707"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76420-231-90)", "package_ndc": "76420-231-90", "marketing_start_date": "20220707"}], "brand_name": "Tizanidne hydrochloride", "product_id": "76420-231_e347f58a-9fc4-7e64-e053-2a95a90a528b", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "76420-231", "generic_name": "Tizanidne Hydrochloride", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidne hydrochloride", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "6 mg/1"}], "application_number": "ANDA212196", "marketing_category": "ANDA", "marketing_start_date": "20190329", "listing_expiration_date": "20261231"}