Home NDC 85766-230 Tetracaine Hydrochloride
Product NDC 85766-230
11-digit product format 857660230
Labeler code 85766
Product ID 85766-230_55ae4e05-add3-45b4-e063-6394a90a7209
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tetracaine Hydrochloride
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Sportpharm LLC
Application ANDA217227
Marketing category ANDA
Marketing start 2024-12-23
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 43 .
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 A217227-001 TETRACAINE HYDROCHLORIDE TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC AB1 2024-12-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217227-001 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.
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 2026-09-14 22:38:34 2026-08 A217227-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC AB1 2024-12-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217227-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC AB1 2024-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217227-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC AB1 2024-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217227-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC AB1 2024-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217227-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC AB1 2024-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217227-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC AB1 2024-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217227-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC AB1 2024-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217227-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC AB1 2024-12-20 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217227-001 TETRACAINE HYDROCHLORIDE 0.5% SOLUTION / OPHTHALMIC AB1 2024-12-20 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217227-001 CGT 2025-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217227-001 CGT 2025-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217227-001 CGT 2025-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217227-001 CGT 2025-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217227-001 CGT 2025-06-25 03ed91905a0d…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85766-230-15 85766023015 1 BOTTLE in 1 CARTON (85766-230-15) / 15 mL in 1 BOTTLE 1 bottle 2026-07-03 No No Current