tizanidne hydrochloride

Generic: tizanidne hydrochloride

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidne hydrochloride
Generic Name tizanidne hydrochloride
Labeler ascend laboratories, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 4 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-611
Product ID 67877-611_628c23e5-c9ed-453b-a83e-1514d6b02912
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 67877611
Hyphenated Format 67877-611

Supplemental Identifiers

RxCUI
485484 485485 485486
UNII
B53E3NMY5C

Packaging Origin

Original Packager
true

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
  • 4 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (67877-611-05)
  • 150 CAPSULE in 1 BOTTLE (67877-611-15)
  • 1 BLISTER PACK in 1 CARTON (67877-611-33) / 10 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (3)

67877-611-05 500 CAPSULE in 1 BOTTLE (67877-611-05) 67877-611-15 150 CAPSULE in 1 BOTTLE (67877-611-15) 67877-611-33 1 BLISTER PACK in 1 CARTON (67877-611-33) / 10 CAPSULE in 1 BLISTER PACK

Ingredients (1)

tizanidine hydrochloride (4 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": "628c23e5-c9ed-453b-a83e-1514d6b02912", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["485484", "485485", "485486"], "spl_set_id": ["d7c97b79-da59-4e86-a01b-f91046d04f74"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (67877-611-05)", "package_ndc": "67877-611-05", "marketing_start_date": "20190329"}, {"sample": false, "description": "150 CAPSULE in 1 BOTTLE (67877-611-15)", "package_ndc": "67877-611-15", "marketing_start_date": "20190329"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (67877-611-33)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "67877-611-33", "marketing_start_date": "20190329"}], "brand_name": "Tizanidne hydrochloride", "product_id": "67877-611_628c23e5-c9ed-453b-a83e-1514d6b02912", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "67877-611", "generic_name": "Tizanidne hydrochloride", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidne hydrochloride", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA212196", "marketing_category": "ANDA", "marketing_start_date": "20190329", "listing_expiration_date": "20261231"}