Home NDC 50090-2364 Tetracaine Hydrochloride
Product NDC 50090-2364
11-digit product format 500902364
Labeler code 50090
Product ID 50090-2364_c7b72c56-5267-471a-8370-55a0f0122e5f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tetracaine hydrochloride
Dosage form SOLUTION
Route OPHTHALMIC
Labeler A-S Medication Solutions
Application NDA208135
Marketing category NDA
Marketing start 2016-11-02
Substance TETRACAINE HYDROCHLORIDE
Active strength 5 mg/mL
Pharmacologic classes Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-2364-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-2364-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-2364-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-2364-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-2364-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-2364-0 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208135-001 TETRACAINE HYDROCHLORIDE TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208135-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2016-02-29 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Tetracaine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TETRACAINE HYDROCHLORIDE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5NF5D4OPCI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1547771 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-2364-1 Tetracaine Hydrochloride 4 mL in 1 BOTTLE, DROPPER SOLUTION 4 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-2364 TETRACAINE HYDROCHLORIDE SOLUTION [A-S MEDICATION SOLUTIONS] 9 Current NDC, 1 package rows 20250213_23c40ef8-6338-46f8-aca9-1aa4f3b2207b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-2364-1 50090236401 4 mL in 1 BOTTLE, DROPPER (50090-2364-1) 4 ml 2019-09-23 No No Current