Home NDC 82260-920 Tetracaine Hydrochloride
Product NDC 82260-920
11-digit product format 822600920
Labeler code 82260
Product ID 82260-920_4a468703-7613-0c8b-e063-6294a90a2f6e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tetracaine Hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Bausch & Lomb Americas Inc.
Application NDA210821
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-09-21
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 2027-12-31
Current FDA listing Yes 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 N210821-001 TETRACAINE HYDROCHLORIDE TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC AB1 RLD, RS 2019-03-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N210821-001 AB1
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 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC AB1 RLD, RS 2019-03-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC AB1 RLD, RS 2019-03-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC AB1 RLD, RS 2019-03-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC AB1 RLD, RS 2019-03-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC AB1 RLD, RS 2019-03-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC AB1 RLD, RS 2019-03-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC 2019-03-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC 2019-03-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC 2019-03-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC 2019-03-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC 2019-03-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210821-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC RLD, RS 2019-03-12 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Tetracaine Hydrochloride
Listing expiration 2027-12-31 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 82260-920-05 Tetracaine Hydrochloride 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 4 82260-920-05 Tetracaine Hydrochloride 1 in 1 CARTON SOLUTION/ DROPS 1 4 82260-920-15 Tetracaine Hydrochloride 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 4 82260-920-15 Tetracaine Hydrochloride 1 in 1 CARTON SOLUTION/ DROPS 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82260-920 TETRACAINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB AMERICAS INC.] 3 Current NDC, Legacy NDC, 4 package rows 20240823_f12d5944-0d6c-43ff-89fd-e0b5669e9b4a.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 82260-920-05 82260092005 1 BOTTLE, DROPPER in 1 CARTON (82260-920-05) / 5 mL in 1 BOTTLE, DROPPER 2022-09-21 0000-00-00 No No Current 82260-920-15 82260092015 1 BOTTLE, DROPPER in 1 CARTON (82260-920-15) / 15 mL in 1 BOTTLE, DROPPER 2022-09-21 0000-00-00 No No Current