cyclopentolate hydrochloride

Generic: cyclopentolate hydrochloride

Labeler: sandoz inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclopentolate hydrochloride
Generic Name cyclopentolate hydrochloride
Labeler sandoz inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

cyclopentolate hydrochloride 10 mg/mL

Manufacturer
Sandoz Inc.

Identifiers & Regulatory

Product NDC 61314-396
Product ID 61314-396_6b554ca9-699a-4d71-8e46-0130c675ca3c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084110
Listing Expiration 2026-12-31
Marketing Start 2002-08-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314396
Hyphenated Format 61314-396

Supplemental Identifiers

RxCUI
1298066
UPC
0361314396037
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 cyclopentolate hydrochloride (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
  • 2 mL in 1 BOTTLE (61314-396-01)
  • 5 mL in 1 BOTTLE (61314-396-02)
  • 15 mL in 1 BOTTLE (61314-396-03)
source: ndc

Packages (3)

61314-396-01 2 mL in 1 BOTTLE (61314-396-01) 61314-396-02 5 mL in 1 BOTTLE (61314-396-02) 61314-396-03 15 mL in 1 BOTTLE (61314-396-03)

Ingredients (1)

cyclopentolate hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Cyclopentolate Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "6b554ca9-699a-4d71-8e46-0130c675ca3c", "openfda": {"upc": ["0361314396037"], "unii": ["736I6971TE"], "rxcui": ["1298066"], "spl_set_id": ["c1b44f91-356d-4804-9509-3b457f4809e5"], "manufacturer_name": ["Sandoz Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 mL in 1 BOTTLE (61314-396-01)", "package_ndc": "61314-396-01", "marketing_start_date": "20020822"}, {"sample": false, "description": "5 mL in 1 BOTTLE (61314-396-02)", "package_ndc": "61314-396-02", "marketing_start_date": "20020822"}, {"sample": false, "description": "15 mL in 1 BOTTLE (61314-396-03)", "package_ndc": "61314-396-03", "marketing_start_date": "20020822"}], "brand_name": "Cyclopentolate Hydrochloride", "product_id": "61314-396_6b554ca9-699a-4d71-8e46-0130c675ca3c", "dosage_form": "SOLUTION", "product_ndc": "61314-396", "generic_name": "Cyclopentolate Hydrochloride", "labeler_name": "Sandoz Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclopentolate Hydrochloride", "active_ingredients": [{"name": "CYCLOPENTOLATE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA084110", "marketing_category": "ANDA", "marketing_start_date": "20020822", "listing_expiration_date": "20261231"}