tizanidine hydrochloride

Generic: tizanidine hydrochloride

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tizanidine hydrochloride
Generic Name tizanidine hydrochloride
Labeler alembic pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

tizanidine hydrochloride 2 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-491
Product ID 46708-491_cf7c5bb7-d94b-4c98-a4a2-e6a917e4165b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213223
Listing Expiration 2026-12-31
Marketing Start 2020-01-15

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 46708491
Hyphenated Format 46708-491

Supplemental Identifiers

RxCUI
485484 485485 485486
UPC
0346708491307
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 tizanidine hydrochloride (source: ndc)
Generic Name tizanidine hydrochloride (source: ndc)
Application Number ANDA213223 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 80 BLISTER PACK in 1 CARTON (46708-491-08) / 8 CAPSULE in 1 BLISTER PACK
  • 30 CAPSULE in 1 BOTTLE (46708-491-30)
  • 150 CAPSULE in 1 BOTTLE (46708-491-41)
  • 1000 CAPSULE in 1 BOTTLE (46708-491-91)
source: ndc

Packages (4)

46708-491-08 80 BLISTER PACK in 1 CARTON (46708-491-08) / 8 CAPSULE in 1 BLISTER PACK 46708-491-30 30 CAPSULE in 1 BOTTLE (46708-491-30) 46708-491-41 150 CAPSULE in 1 BOTTLE (46708-491-41) 46708-491-91 1000 CAPSULE in 1 BOTTLE (46708-491-91)

Ingredients (1)

tizanidine hydrochloride (2 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": "cf7c5bb7-d94b-4c98-a4a2-e6a917e4165b", "openfda": {"upc": ["0346708491307"], "unii": ["B53E3NMY5C"], "rxcui": ["485484", "485485", "485486"], "spl_set_id": ["29750221-497e-4747-a9b8-12a0c2236eae"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "80 BLISTER PACK in 1 CARTON (46708-491-08)  / 8 CAPSULE in 1 BLISTER PACK", "package_ndc": "46708-491-08", "marketing_start_date": "20200115"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (46708-491-30)", "package_ndc": "46708-491-30", "marketing_start_date": "20200115"}, {"sample": false, "description": "150 CAPSULE in 1 BOTTLE (46708-491-41)", "package_ndc": "46708-491-41", "marketing_start_date": "20200115"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (46708-491-91)", "package_ndc": "46708-491-91", "marketing_start_date": "20200115"}], "brand_name": "Tizanidine Hydrochloride", "product_id": "46708-491_cf7c5bb7-d94b-4c98-a4a2-e6a917e4165b", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "46708-491", "generic_name": "Tizanidine Hydrochloride", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tizanidine Hydrochloride", "active_ingredients": [{"name": "TIZANIDINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA213223", "marketing_category": "ANDA", "marketing_start_date": "20200115", "listing_expiration_date": "20261231"}