cyclogyl

Generic: cyclopentolate hydrochloride

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

Drug Facts

Product Profile

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

cyclopentolate hydrochloride 10 mg/mL

Manufacturer
Alcon Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0065-0396
Product ID 0065-0396_2fc4fc5f-9c4a-456e-9476-7791f6f9c3c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084110
Listing Expiration 2026-12-31
Marketing Start 1975-10-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00650396
Hyphenated Format 0065-0396

Supplemental Identifiers

RxCUI
1298066 1298070 1298072 1298356 1298364 1298366
UPC
0300650396059
UNII
736I6971TE

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 cyclogyl (source: ndc)
Generic Name cyclopentolate hydrochloride (source: ndc)
Application Number ANDA084110 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (0065-0396-02) / 2 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (0065-0396-05) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

0065-0396-02 1 BOTTLE, PLASTIC in 1 CARTON (0065-0396-02) / 2 mL in 1 BOTTLE, PLASTIC 0065-0396-05 1 BOTTLE, PLASTIC in 1 CARTON (0065-0396-05) / 5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

cyclopentolate hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Cyclogyl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "2fc4fc5f-9c4a-456e-9476-7791f6f9c3c1", "openfda": {"upc": ["0300650396059"], "unii": ["736I6971TE"], "rxcui": ["1298066", "1298070", "1298072", "1298356", "1298364", "1298366"], "spl_set_id": ["1d008c76-7210-4ace-90fa-7cd22762e12e"], "manufacturer_name": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0065-0396-02)  / 2 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0065-0396-02", "marketing_start_date": "19751015"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0065-0396-05)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0065-0396-05", "marketing_start_date": "19751015"}], "brand_name": "Cyclogyl", "product_id": "0065-0396_2fc4fc5f-9c4a-456e-9476-7791f6f9c3c1", "dosage_form": "SOLUTION/ DROPS", "product_ndc": "0065-0396", "generic_name": "cyclopentolate hydrochloride", "labeler_name": "Alcon Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclogyl", "active_ingredients": [{"name": "CYCLOPENTOLATE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA084110", "marketing_category": "ANDA", "marketing_start_date": "19751015", "listing_expiration_date": "20261231"}