dantrolene sodium

Generic: dantrolene sodium

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dantrolene sodium
Generic Name dantrolene sodium
Labeler amneal pharmaceuticals of new york llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dantrolene sodium 100 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-4433
Product ID 0115-4433_020cc0ba-19eb-4442-b55f-6820c32b4754
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076856
Listing Expiration 2026-12-31
Marketing Start 2005-03-01

Pharmacologic Class

Classes
decreased striated muscle contraction [pe] decreased striated muscle tone [pe] skeletal muscle relaxant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01154433
Hyphenated Format 0115-4433

Supplemental Identifiers

RxCUI
856652 856656 856660
UNII
287M0347EV

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 dantrolene sodium (source: ndc)
Generic Name dantrolene sodium (source: ndc)
Application Number ANDA076856 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0115-4433-01)
  • 500 CAPSULE in 1 BOTTLE (0115-4433-02)
  • 1000 CAPSULE in 1 BOTTLE (0115-4433-03)
source: ndc

Packages (3)

0115-4433-01 100 CAPSULE in 1 BOTTLE (0115-4433-01) 0115-4433-02 500 CAPSULE in 1 BOTTLE (0115-4433-02) 0115-4433-03 1000 CAPSULE in 1 BOTTLE (0115-4433-03)

Ingredients (1)

dantrolene sodium (100 mg/1)

Linked Drug Pages (1)

Dantrolene Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "020cc0ba-19eb-4442-b55f-6820c32b4754", "openfda": {"unii": ["287M0347EV"], "rxcui": ["856652", "856656", "856660"], "spl_set_id": ["c3c45b27-f786-456e-95d6-2e38ef36190a"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0115-4433-01)", "package_ndc": "0115-4433-01", "marketing_start_date": "20050301"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (0115-4433-02)", "package_ndc": "0115-4433-02", "marketing_start_date": "20050301"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (0115-4433-03)", "package_ndc": "0115-4433-03", "marketing_start_date": "20050301"}], "brand_name": "Dantrolene Sodium", "product_id": "0115-4433_020cc0ba-19eb-4442-b55f-6820c32b4754", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Striated Muscle Contraction [PE]", "Decreased Striated Muscle Tone [PE]", "Skeletal Muscle Relaxant [EPC]"], "product_ndc": "0115-4433", "generic_name": "Dantrolene Sodium", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dantrolene Sodium", "active_ingredients": [{"name": "DANTROLENE SODIUM", "strength": "100 mg/1"}], "application_number": "ANDA076856", "marketing_category": "ANDA", "marketing_start_date": "20050301", "listing_expiration_date": "20261231"}