tizanidine

Generic: tizanidine

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 4 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-760
Product ID 50268-760_4823baf7-5542-f52e-e063-6394a90abeee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076286
Listing Expiration 2027-12-31
Marketing Start 2017-08-24

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 50268760
Hyphenated Format 50268-760

Supplemental Identifiers

RxCUI
313412 313413
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 tizanidine (source: ndc)
Generic Name tizanidine (source: ndc)
Application Number ANDA076286 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-760-15) / 1 TABLET in 1 BLISTER PACK (50268-760-11)
source: ndc

Packages (1)

50268-760-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-760-15) / 1 TABLET in 1 BLISTER PACK (50268-760-11)

Ingredients (1)

tizanidine hydrochloride (4 mg/1)

Linked Drug Pages (1)

Tizanidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4823baf7-5542-f52e-e063-6394a90abeee", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313412", "313413"], "spl_set_id": ["b694225c-1fa9-4726-89a6-fd3f87084248"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-760-15)  / 1 TABLET in 1 BLISTER PACK (50268-760-11)", "package_ndc": "50268-760-15", "marketing_start_date": "20170824"}], "brand_name": "Tizanidine", "product_id": "50268-760_4823baf7-5542-f52e-e063-6394a90abeee", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "50268-760", "generic_name": "Tizanidine", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA076286", "marketing_category": "ANDA", "marketing_start_date": "20170824", "listing_expiration_date": "20271231"}