tetracaine hydrochloride

Generic: tetracaine hydrochloride

Labeler: oceanside pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tetracaine hydrochloride
Generic Name tetracaine hydrochloride
Labeler oceanside pharmaceuticals
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

tetracaine hydrochloride 5 mg/mL

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-920
Product ID 68682-920_48ec9821-6f9b-2a1b-e063-6394a90a1d98
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210821
Marketing Start 2019-06-27
Marketing End 2027-04-30

Pharmacologic Class

Classes
ester local anesthetic [epc] esters [cs] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68682920
Hyphenated Format 68682-920

Supplemental Identifiers

RxCUI
1547771
UNII
5NF5D4OPCI

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 tetracaine hydrochloride (source: ndc)
Generic Name tetracaine hydrochloride (source: ndc)
Application Number NDA210821 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68682-920-05) / 5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (68682-920-64) / 15 mL in 1 BOTTLE
source: ndc

Packages (2)

68682-920-05 1 BOTTLE in 1 CARTON (68682-920-05) / 5 mL in 1 BOTTLE 68682-920-64 1 BOTTLE in 1 CARTON (68682-920-64) / 15 mL in 1 BOTTLE

Ingredients (1)

tetracaine hydrochloride (5 mg/mL)

Linked Drug Pages (1)

Tetracaine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "48ec9821-6f9b-2a1b-e063-6394a90a1d98", "openfda": {"unii": ["5NF5D4OPCI"], "rxcui": ["1547771"], "spl_set_id": ["807dae5d-f34a-4f3d-9f54-dd350b056a92"], "manufacturer_name": ["Oceanside Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68682-920-05)  / 5 mL in 1 BOTTLE", "package_ndc": "68682-920-05", "marketing_end_date": "20270430", "marketing_start_date": "20200405"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (68682-920-64)  / 15 mL in 1 BOTTLE", "package_ndc": "68682-920-64", "marketing_end_date": "20270430", "marketing_start_date": "20190627"}], "brand_name": "Tetracaine Hydrochloride", "product_id": "68682-920_48ec9821-6f9b-2a1b-e063-6394a90a1d98", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Ester Local Anesthetic [EPC]", "Esters [CS]", "Local Anesthesia [PE]"], "product_ndc": "68682-920", "generic_name": "Tetracaine Hydrochloride", "labeler_name": "Oceanside Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tetracaine Hydrochloride", "active_ingredients": [{"name": "TETRACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "NDA210821", "marketing_category": "NDA", "marketing_end_date": "20270430", "marketing_start_date": "20190627"}