cyclomydril

Generic: cyclopentolate hydrochloride and phenylephrine hydrochloride

Labeler: alcon laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclomydril
Generic Name cyclopentolate hydrochloride and phenylephrine hydrochloride
Labeler alcon laboratories, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

cyclopentolate hydrochloride 2 mg/mL, phenylephrine hydrochloride 10 mg/mL

Manufacturer
Alcon Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0065-0359
Product ID 0065-0359_3c5dad7d-4db2-4615-92cb-01ea4d769adf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084300
Listing Expiration 2026-12-31
Marketing Start 1958-06-30

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00650359
Hyphenated Format 0065-0359

Supplemental Identifiers

RxCUI
1298068 1298360
UPC
0300650359054
UNII
736I6971TE 04JA59TNSJ

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 cyclomydril (source: ndc)
Generic Name cyclopentolate hydrochloride and phenylephrine hydrochloride (source: ndc)
Application Number ANDA084300 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
  • 10 mg/mL
source: ndc
Packaging
  • 2 mL in 1 BOTTLE, PLASTIC (0065-0359-02)
  • 5 mL in 1 BOTTLE, PLASTIC (0065-0359-05)
source: ndc

Packages (2)

0065-0359-02 2 mL in 1 BOTTLE, PLASTIC (0065-0359-02) 0065-0359-05 5 mL in 1 BOTTLE, PLASTIC (0065-0359-05)

Ingredients (2)

cyclopentolate hydrochloride (2 mg/mL) phenylephrine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Cyclomydril ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "3c5dad7d-4db2-4615-92cb-01ea4d769adf", "openfda": {"upc": ["0300650359054"], "unii": ["736I6971TE", "04JA59TNSJ"], "rxcui": ["1298068", "1298360"], "spl_set_id": ["8268b70f-3f10-48dd-bb24-baaeb27a1325"], "manufacturer_name": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 mL in 1 BOTTLE, PLASTIC (0065-0359-02)", "package_ndc": "0065-0359-02", "marketing_start_date": "19580630"}, {"sample": false, "description": "5 mL in 1 BOTTLE, PLASTIC (0065-0359-05)", "package_ndc": "0065-0359-05", "marketing_start_date": "19580630"}], "brand_name": "Cyclomydril", "product_id": "0065-0359_3c5dad7d-4db2-4615-92cb-01ea4d769adf", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0065-0359", "generic_name": "cyclopentolate hydrochloride and phenylephrine hydrochloride", "labeler_name": "Alcon Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclomydril", "active_ingredients": [{"name": "CYCLOPENTOLATE HYDROCHLORIDE", "strength": "2 mg/mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA084300", "marketing_category": "ANDA", "marketing_start_date": "19580630", "listing_expiration_date": "20261231"}