tizanidine

Generic: tizanidine

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine
Generic Name tizanidine
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 2 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-868
Product ID 43063-868_3a214bf4-ea51-0892-e063-6394a90a9a9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091283
Listing Expiration 2026-12-31
Marketing Start 2013-04-01

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 43063868
Hyphenated Format 43063-868

Supplemental Identifiers

RxCUI
313412
UPC
0343063868607
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 ANDA091283 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 12 TABLET in 1 BOTTLE, PLASTIC (43063-868-12)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-868-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-868-60)
source: ndc

Packages (3)

43063-868-12 12 TABLET in 1 BOTTLE, PLASTIC (43063-868-12) 43063-868-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-868-30) 43063-868-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-868-60)

Ingredients (1)

tizanidine hydrochloride (2 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": "3a214bf4-ea51-0892-e063-6394a90a9a9d", "openfda": {"upc": ["0343063868607"], "unii": ["B53E3NMY5C"], "rxcui": ["313412"], "spl_set_id": ["615dfd5c-125a-40e2-a6da-afacde305282"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET in 1 BOTTLE, PLASTIC (43063-868-12)", "package_ndc": "43063-868-12", "marketing_start_date": "20180709"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-868-30)", "package_ndc": "43063-868-30", "marketing_start_date": "20180709"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-868-60)", "package_ndc": "43063-868-60", "marketing_start_date": "20180709"}], "brand_name": "Tizanidine", "product_id": "43063-868_3a214bf4-ea51-0892-e063-6394a90a9a9d", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "43063-868", "generic_name": "Tizanidine", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA091283", "marketing_category": "ANDA", "marketing_start_date": "20130401", "listing_expiration_date": "20261231"}