dantrolene sodium

Generic: dantrolene sodium

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name dantrolene sodium
Generic Name dantrolene sodium
Labeler endo usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dantrolene sodium 25 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 49884-362
Product ID 49884-362_eaaa53d2-744b-4529-ad62-84ab6b4fdd51
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA017443
Listing Expiration 2026-12-31
Marketing Start 2016-03-28

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 49884362
Hyphenated Format 49884-362

Supplemental Identifiers

RxCUI
856652 856656 856660
UPC
0349884363017 0349884364014
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 NDA017443 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (49884-362-01)
source: ndc

Packages (1)

49884-362-01 100 CAPSULE in 1 BOTTLE (49884-362-01)

Ingredients (1)

dantrolene sodium (25 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": "eaaa53d2-744b-4529-ad62-84ab6b4fdd51", "openfda": {"upc": ["0349884363017", "0349884364014"], "unii": ["287M0347EV"], "rxcui": ["856652", "856656", "856660"], "spl_set_id": ["11689f56-15e0-4350-b53f-ae96e5994fea"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (49884-362-01)", "package_ndc": "49884-362-01", "marketing_start_date": "20160328"}], "brand_name": "dantrolene sodium", "product_id": "49884-362_eaaa53d2-744b-4529-ad62-84ab6b4fdd51", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Striated Muscle Contraction [PE]", "Decreased Striated Muscle Tone [PE]", "Skeletal Muscle Relaxant [EPC]"], "product_ndc": "49884-362", "generic_name": "dantrolene sodium", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "dantrolene sodium", "active_ingredients": [{"name": "DANTROLENE SODIUM", "strength": "25 mg/1"}], "application_number": "NDA017443", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20160328", "listing_expiration_date": "20261231"}