tizanidine hydrochloride

Generic: tizanidine hydrochloride

Labeler: quality care products llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine hydrochloride
Generic Name tizanidine hydrochloride
Labeler quality care products llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 4 mg/1

Manufacturer
Quality Care Products LLC

Identifiers & Regulatory

Product NDC 49999-347
Product ID 49999-347_adbf3ce7-64fd-4df3-aa6f-9f4b459b2976
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076286
Marketing Start 2010-11-23
Marketing End 2027-04-30

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 49999347
Hyphenated Format 49999-347

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE, PLASTIC (49999-347-01)
  • 30 TABLET in 1 BOTTLE, PLASTIC (49999-347-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (49999-347-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (49999-347-90)
source: ndc

Packages (4)

49999-347-01 120 TABLET in 1 BOTTLE, PLASTIC (49999-347-01) 49999-347-30 30 TABLET in 1 BOTTLE, PLASTIC (49999-347-30) 49999-347-60 60 TABLET in 1 BOTTLE, PLASTIC (49999-347-60) 49999-347-90 90 TABLET in 1 BOTTLE, PLASTIC (49999-347-90)

Ingredients (1)

tizanidine hydrochloride (4 mg/1)

Linked Drug Pages (1)

Tizanidine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "adbf3ce7-64fd-4df3-aa6f-9f4b459b2976", "openfda": {"unii": ["B53E3NMY5C"], "rxcui": ["313413"], "spl_set_id": ["87f8a776-e8ae-4aed-a221-98ca72a2bedf"], "manufacturer_name": ["Quality Care Products LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (49999-347-01)", "package_ndc": "49999-347-01", "marketing_end_date": "20261031", "marketing_start_date": "20101123"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (49999-347-30)", "package_ndc": "49999-347-30", "marketing_end_date": "20270430", "marketing_start_date": "20101123"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (49999-347-60)", "package_ndc": "49999-347-60", "marketing_end_date": "20270430", "marketing_start_date": "20101123"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (49999-347-90)", "package_ndc": "49999-347-90", "marketing_end_date": "20270430", "marketing_start_date": "20101123"}], "brand_name": "Tizanidine Hydrochloride", "product_id": "49999-347_adbf3ce7-64fd-4df3-aa6f-9f4b459b2976", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "49999-347", "generic_name": "Tizanidine Hydrochloride", "labeler_name": "Quality Care Products LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine Hydrochloride", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA076286", "marketing_category": "ANDA", "marketing_end_date": "20270430", "marketing_start_date": "20101123"}