Home NDC 0187-0920 Tetracaine Hydrochloride
Product NDC 0187-0920
11-digit product format 001870920
Labeler code 0187
Product ID 0187-0920_453da1ac-7306-7a40-e063-6394a90a741c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tetracaine Hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Bausch Health US LLC
Application NDA210821
Marketing category NDA
Marketing start 2019-06-27
Marketing end 2027-04-30
Substance TETRACAINE HYDROCHLORIDE
Active strength 5 mg/mL
Pharmacologic classes Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
NDC exclude flag No
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 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 0187-0920-05 Tetracaine Hydrochloride 5 mL in 1 BOTTLE SOLUTION/ DROPS 5 2 0187-0920-05 Tetracaine Hydrochloride 1 in 1 CARTON SOLUTION/ DROPS 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0187-0920 TETRACAINE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH HEALTH US LLC] 1 Current NDC, Legacy NDC, 2 package rows 20200417_78404c9e-9c31-4b0a-90f4-04182e82e183.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 Units Marketing start Marketing end Sample Exclude flag Status 0187-0920-05 00187092005 1 BOTTLE in 1 CARTON (0187-0920-05) / 5 mL in 1 BOTTLE 1 bottle 2019-06-27 2027-04-30 No No Current