dimenhydrinate

Generic: dimenhydrinate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dimenhydrinate
Generic Name dimenhydrinate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

dimenhydrinate 50 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-366
Product ID 63323-366_b3e3433d-c18b-4ed3-b2ba-1e550474ca33
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040519
Listing Expiration 2026-12-31
Marketing Start 2004-11-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323366
Hyphenated Format 63323-366

Supplemental Identifiers

RxCUI
309914
UPC
0363323366001
UNII
JB937PER5C

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 dimenhydrinate (source: ndc)
Generic Name dimenhydrinate (source: ndc)
Application Number ANDA040519 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 TRAY (63323-366-01) / 1 mL in 1 VIAL (63323-366-00)
source: ndc

Packages (1)

63323-366-01 25 VIAL in 1 TRAY (63323-366-01) / 1 mL in 1 VIAL (63323-366-00)

Ingredients (1)

dimenhydrinate (50 mg/mL)

Linked Drug Pages (1)

Dimenhydrinate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "b3e3433d-c18b-4ed3-b2ba-1e550474ca33", "openfda": {"upc": ["0363323366001"], "unii": ["JB937PER5C"], "rxcui": ["309914"], "spl_set_id": ["bc71539e-1a33-4709-8a24-c2894e8dbc1c"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (63323-366-01)  / 1 mL in 1 VIAL (63323-366-00)", "package_ndc": "63323-366-01", "marketing_start_date": "20041129"}], "brand_name": "Dimenhydrinate", "product_id": "63323-366_b3e3433d-c18b-4ed3-b2ba-1e550474ca33", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "63323-366", "generic_name": "Dimenhydrinate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dimenhydrinate", "active_ingredients": [{"name": "DIMENHYDRINATE", "strength": "50 mg/mL"}], "application_number": "ANDA040519", "marketing_category": "ANDA", "marketing_start_date": "20041129", "listing_expiration_date": "20261231"}